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Completed

NCT Number: NCT00317135

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

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases 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 Pasteurellaceae Infections Tetanus Virus Diseases Whole Cell Pertussis

Age range

Up to 3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

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

at study entry:

  • Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria

at study entry:

  • Any confirmed immunodeficient condition, based on medical history & physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Acute disease at the time of enrolment.

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

Assess Reactogenicity and Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Compared to Tritanrix™-HepB/Hiberix™ (Control) in Healthy Infants (2,4,6 Months Age), After a Hepatitis B Birth Dose

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
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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