Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

NCT00317109 | Completed Phase 3 Results

• 1 other identifier: 104756
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Meningococcal

Keywords

meningococcal serogroups A and C diseases; tetanus; hepatitis B; pertussis; Haemophilus influenzae type b; meningococcal vaccine; Prophylaxis diphtheria

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies

  Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.

  At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)

Secondary Outcomes (14)

• Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs

  Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

• Anti-rSBA-MenA, C, W-135 Antibody Titers

  Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

• Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values

  Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

• Anti-PSA and Anti-PSC Antibody Concentrations

  Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31

• Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values

  Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)

Study Arms (2)

AC primed Group

EXPERIMENTAL

Biological: Tritanrix™- HepB; Biological: Hiberix™; Biological: Mencevax™ ACW

AC unprimed Group

ACTIVE COMPARATOR

Biological: Tritanrix™- HepB; Biological: Hiberix™; Biological: Mencevax™ ACW

Interventions

Tritanrix™- HepB BIOLOGICAL

One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months

AC primed Group; AC unprimed Group

Hiberix™ BIOLOGICAL

One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months

AC primed Group; AC unprimed Group

Mencevax™ ACW BIOLOGICAL

One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

AC primed Group; AC unprimed Group

Eligibility Criteria

• Age: 15 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 15 and 18 months of age at the time of vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Having participated in the primary vaccination study (CPMS N° 759346/007).

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
• Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
• History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
• Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures including febrile seizures in infancy.
• Acute disease at the time of enrolment.
• Axillary temperature ≥ 37.5°C at the time of vaccination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
• Anaphylactic reaction following the administration of vaccine in the primary vaccination study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Brits, 0250, South Africa

Location

GSK Investigational Site

Ga-Rankuwa, 0208, South Africa

Location

GSK Investigational Site

Rooihuiskraal, 0145, South Africa

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Meningococcal Infections; Tetanus; Hepatitis B; Whooping Cough; Haemophilus Infections

Interventions

Hiberix

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Gram-Positive Bacterial Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pasteurellaceae Infections

Limitations and Caveats

None reported.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: April 24, 2006
• Study Start: April 19, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 17, 2007
• Last Updated: June 6, 2018
• Results First Posted: March 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

ZA (3)