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

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ClinicalTrials.gov Identifier: NCT00317187
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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™.

Condition or disease Intervention/treatment Phase
Hepatitis B Diphtheria Whole Cell Pertussis Tetanus Haemophilus Influenzae Type b Biological: Tritanrix-HepB/Meningitec conjugate vaccine Biological: Tritanrix/Hiberix vaccine Phase 3

Detailed Description:

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™

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official 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
Actual Study Start Date : June 8, 2004
Actual Primary Completion Date : January 16, 2005
Actual Study Completion Date : January 16, 2005


Arm Intervention/treatment
Experimental: Hib-MenAC Lot 1 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Biological: Tritanrix-HepB/Meningitec conjugate vaccine
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 Name: DTPw-HBV/Hib-MenAC conjugate vaccine

Experimental: Hib-MenAC Lot 2 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Biological: Tritanrix-HepB/Meningitec conjugate vaccine
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 Name: DTPw-HBV/Hib-MenAC conjugate vaccine

Experimental: Hib-MenAC Lot 3 Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Biological: Tritanrix-HepB/Meningitec conjugate vaccine
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 Name: DTPw-HBV/Hib-MenAC conjugate vaccine

Active Comparator: Hiberix Group
Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.
Biological: Tritanrix/Hiberix vaccine
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 Name: DTPw-HBV/Hib vaccine




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   56 Days to 83 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317187


Locations
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00317187     History of Changes
Other Study ID Numbers: 100791
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Diphtheria
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs