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Completed

NCT Number: NCT01235949

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age.

In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.

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Key information

Conditions

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

Age range

12 week–16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Bacau, Romania

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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 parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria

  • Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
  • 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 or therapeutic antipyretic treatment during the study period.
  • Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
  • History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
  • History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
  • History of any seizures or progressive neurological disease.
  • Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
  • 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 since birth or planned administration during entire study period.
  • Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC).
  • Any contraindication to treatment with paracetamol as described in the paracetamol SPC.
  • Body weight < 5 kg at the time of enrolment.
  • Child in care.

Treatment and study plan

GSK1024850A (SynflorixTM)

Biological

Intramuscular injection, 4 doses

Infanrix hexa

Biological

Intramuscular injection, 3 doses

Infanrix-IPV/Hib

Biological

Intramuscular injection, 1 dose

Ibuprofen

Drug

Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

Other names: Nurofen for Children

Paracetamol

Drug

Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

Other names: Panadol Baby

Primary outcomes

  1. Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off

    Time frame: One month after primary immunization (At Month 3)

    Antibodies against the vaccine 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) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).

  2. Antibody Concentrations Against Vaccine Pneumococcal Serotypes

    Time frame: One month after primary immunization (At Month 3)

    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

  3. Antibody Concentrations Against Protein D (Anti-PD)

    Time frame: One month after primary immunization (At Month 3)

    Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.

Secondary outcomes

  1. Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A

    Time frame: One month after primary immunization (At Month 3)

    Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

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

    Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

    Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).

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

    Time frame: Within the 4-day (Days 0-3) period following booster vaccination

    Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).

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

    Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

    Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.

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

    Time frame: Within the 4-day (Days 0-3) period following booster vaccination

    Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.

  6. Number of Subjects With Any Serious Adverse Events (SAEs)

    Time frame: During the entire study period (Month 0 to 10)

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.

  7. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    Time frame: Within 31-days (Day 0-30) following each primary vaccination dose

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

  8. Number of Subjects With Any Unsolicited Adverse Events (AEs)

    Time frame: Within 31-days (Day 0-30) following booster vaccination

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

  9. Antibody Concentrations Against Vaccine Pneumococcal Serotypes

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

  10. Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

    Time frame: One month after primary immunization (Month 3)

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

  11. Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value "99999.9" has been entered when value to be entered in the system was greater than (>) 1.0 E10.

  12. Antibody Concentrations Against Protein D (Anti-PD)

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.

  13. Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids

    Time frame: One month after primary immunization (Month 3)

    Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

  14. Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

  15. Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

    Time frame: One month after primary immunization (Month 3)

    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.

  16. Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.

  17. Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)

    Time frame: One month after primary immunization (Month 3)

    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

  18. Antibody Concentrations Against Hepatitis B Surface Antigen

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

  19. Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

    Time frame: One month after primary immunization (Month 3)

    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

  20. Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

  21. Antibody Titers Against Poliovirus Type 1, 2 and 3

    Time frame: One month after primary immunization (Month 3)

    Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

  22. Antibody Titers Against Poliovirus Type 1, 2 and 3

    Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

    Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2010
Registry last updated
May 10, 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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