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Completed

NCT Number: NCT01353703

Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.

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Key information

Conditions

Poliomyelitis Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections RNA Virus Infections Spinal Cord Diseases Tetanus Virus Diseases

Age range

6 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Belgaun, India

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All subjects must satisfy ALL the following criteria at study entry:

  • A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
  • Documented administration of a hepatitis B vaccine dose at birth
  • Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject
  • Healthy subjects as established by medical history and clinical examination before entering into the study
  • Born after a gestation period of at least 36 weeks

Exclusion criteria

The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:

  • Child in care
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
  • Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
  • 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
  • Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Family history of congenital or hereditary immunodeficiency
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
  • Major congenital defects or serious chronic illness
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
  • Acute disease and/or fever at the time of enrolment

Treatment and study plan

Infanrix Hexa™

Biological

Intramuscular, three doses

Other names: DTPa-HBV-IPV/Hib

Primary outcomes

  1. Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  2. Number of Seroprotected Subjects Against Hepatitis B (HBs)

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

  3. Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

  4. Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

  5. Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.

Secondary outcomes

  1. Anti-D and Anti-T Antibody Concentrations

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

  2. Anti-HBs Antibody Concentrations

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

  3. Anti-Polio Types 1, 2, 3 Antibody Titers

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    Antibody titers were presented as geometric mean titers (GMTs).

  4. Anti-PRP Antibody Concentrations

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

  5. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  6. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN

    Time frame: One month post Dose 3 (Month 3 or Month 5)

    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  7. Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens

    Time frame: At Month 0

    A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

  8. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN

    Time frame: At Month 0

    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  9. Number of Seroprotected Subjects Against Anti-HBs Antigens

    Time frame: At Month 0

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

  10. Anti-Polio Types 1, 2 and 3 Antibody Titers

    Time frame: At Month 0

    Antibody titers were presented as geometric mean titers (GMTs).

  11. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Time frame: At Month 0

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

  12. Anti-HBs Antibody Concentrations

    Time frame: At Month 0

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

  13. Number of Subjects With Any Solicited Local Symptoms

    Time frame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)

    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.

  14. Number of Subjects With Solicited General Symptoms

    Time frame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)

    Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.

  15. Number of Subjects With Unsolicited Adverse Events (AEs)

    Time frame: During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 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.

  16. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2011
Registry last updated
Jan 2, 2020

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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