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Completed

NCT Number: NCT00317187

Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

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Key information

Conditions

Hepatitis B Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Pasteurellaceae Infections Tetanus Virus Diseases Whole Cell Pertussis

Age range

56 day–83 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Bangkok, 10400, Thailand

About this study

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

  • One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups)
  • GSK Biologicals' Tritanrix™-HepB/Hiberix™

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.

Exclusion criteria

  • Any confirmed immunodeficient condition, based on medical history and physical examination.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
  • History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Treatment and study plan

Tritanrix-HepB/Meningitec conjugate vaccine

Biological

The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection

Other names: DTPw-HBV/Hib-MenAC conjugate vaccine

Tritanrix/Hiberix vaccine

Biological

The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.

Other names: DTPw-HBV/Hib vaccine

Primary outcomes

  1. Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1

    Time frame: Days 0-3 post dose 1

  2. Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2

    Time frame: Days 0-3 post dose 2

  3. Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3

    Time frame: Days 0-3 post dose 3

Secondary outcomes

  1. Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose

    Time frame: Days 0-3 after each dose

  2. Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose

    Time frame: Day 0-30 after each dose

  3. Occurrence of serious adverse events during the entire study period

    Time frame: Day 0 up to Month 5

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants After a Hepatitis B Birth Dose

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 24, 2006
Registry last updated
Aug 15, 2018

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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