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Completed

NCT Number: NCT00496015

Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612).

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Body Temperature Changes Fever Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections Pathological Conditions, Signs and Symptoms Pneumococcal Infections Signs and Symptoms Streptococcal Infections

Age range

12 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Brno, Czechia

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About this study

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 12-15 months of age at the time of the vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Subjects in the unprimed group

  • A male or female who previously participated in study 107017 and received 3 doses of pneumococcal conjugate vaccine GSK1024850A.

Exclusion criteria

For all subjects:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
  • Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the dose of study vaccines, or planned use during the entire study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the dose of study vaccines and up to one month after the dose of study vaccines.
  • History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Acute disease at the time of enrolment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins and/or any blood products within three months preceding administration of the dose of study vaccines or planned administration during the study period.
  • Subjects of which both parents have a history of atopia.
  • Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
  • Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.

DTPa-HBV-IPV/Hib vaccine:

  • Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
  • Encephalopathy.
  • As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.

For subjects in the AP-AP, AP-NAP and NAP groups:

  • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017.

For subjects in the AP-AP group:

  • Subject with any contraindication to treatment with paracetamol.

For subjects in the unprimed group:

  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
  • Planned administration of a hepatitis B vaccine not foreseen by the study protocol during the period starting one month after the dose of study vaccines and up to study end.
  • Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry.
  • History of meningococcal disease due to serogroup A, C, W, or Y.
  • Administration of any pneumococcal vaccine since birth.
  • Full vaccination history since birth not available.

Treatment and study plan

Pneumococcal conjugate vaccine GSK1024850A.

Biological

1 intramuscular injection.

Infanrix hexa.

Biological

1 intramuscular injection.

Other names: DTPa-HBV-IPV/Hib

Meningococcal vaccine GSK134612.

Biological

1 intramuscular injection.

Other names: Mencevax™

Paracetamol.

Drug

Body weight of < 7 kg: none; Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.

Primary outcomes

  1. Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off

    Time frame: Within 4 days (Day 0-3) after primary vaccine dose.

    The cut-off for core fever was 38.0 degrees Celsius (ºC).

Secondary outcomes

  1. Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

    Time frame: Within 4 days (Day 0-3) after primary vaccination dose

    The cut-off value for core fever (rectal temperature) was 39.0ºC.

  2. Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.

    Time frame: During the 4-day (Days 0-3) post-primary vaccination period

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters (mm) from injection site.

  3. Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms

    Time frame: During the 4-day (Day 0-3) post-vaccination period

    Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature >40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination.

  4. Number of Subjects Reported With Unsolicited Adverse Events (AEs)

    Time frame: Within 31 days (Days 0-30) after primary vaccine dose.

    The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group.

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  5. Number of Subjects Reported With Serious Adverse Events (SAEs)

    Time frame: Throughout the entire study period (Month 0-Month 12)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  6. Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.

    Time frame: Up to 6 months after vaccination with Mencevax™

    Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.

  7. Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off

    Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

    Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

    The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL).

  8. Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.

    Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

    Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).

    Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

    Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).

  9. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

    Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

    OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

  10. Concentrations of Antibodies Against Protein D (Anti-PD)

    Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

    The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).

  11. Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)

    Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

    Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

  12. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A

    Time frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

    OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

  13. Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values

    Time frame: Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination

    The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY).

    Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

  14. rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group

    Time frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

    Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

  15. Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values

    Time frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination

    Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

  16. Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations

    Time frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

    Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

  17. Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

    Time frame: Prior to vaccination (Pre)

    The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

  18. Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

    Time frame: Prior to vaccination (Pre)

    The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1.

  19. Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).

    Time frame: 1 month post-vaccination (M1)

    The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

  20. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

    Time frame: 1 month post-vaccination (M1)

    The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).

  21. Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

    Time frame: 1 month post-vaccination (M1)

    The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

  22. Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

    Time frame: 1 month post-vaccination (M1)

    The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.

  23. Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers

    Time frame: 1 month post-vaccination (M1)

    The seroprotection cut-off for the assay was ≥ 8.

  24. Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

    Time frame: 12 month post-vaccination (M12)

    The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

  25. Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers

    Time frame: 12 month post-vaccination (M12)

    The seroprotection cut-off for the assay was ≥ 8.

  26. Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)

    Time frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

    Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

  27. Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)

    Time frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

    Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

  28. Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)

    Time frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  29. Number of Nasopharyngeal Swabs With H. Influenzae

    Time frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  30. Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae

    Time frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  31. Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs

    Time frame: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  32. Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.

    Time frame: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Vaccine GSK1024850A and DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa) and Assessment of Impact of Pneumococcal Vaccination on Nasopharyngeal Carriage

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jul 4, 2007
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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