Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine

NCT01105559 | Completed

• 2 other identifiers: A3L26UTN: U1111-1111-5789
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336). Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Keywords

Diphtheria; Tetanus; Whooping cough; Hepatitis B; Poliomyelitis; Diphtheria-Tetanus-acellular Pertussis Vaccines

Outcome Measures

Primary Outcomes (1)

• The antibody titers for each valence of DTaP-IPV-Hep B-PRP-T vaccine (except poliovirus) post-primary and booster vaccination.

  Age 3.5 and 4.5 years after infant and booster vaccination

Study Arms (3)

Group 1

Participants previously received 3 doses and a booster dose of the investigational vaccine DTaP IPV Hep B PRP-T.

Group 2

Participants previously received 3 doses CombAct-Hib™ + Engerix™ B + OPV and a booster dose of CombAct-Hib™ + Oral poliovirus vaccine (OPV) vaccine.

Group 3

Participants previously received 3 doses DTaP IPV Hep B PRP-T; a dose of Engerix™ B at birth, and a booster dose of DTaP IPV Hep B PRP-T vaccine.

Eligibility Criteria

• Age: 41 Months - 43 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged 3 years and a half on the day of inclusion and must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336). No vaccination will be provided or administered in this study.

You may qualify if:

• Informed consent form signed by a parent or other legally acceptable representative and by an independent witness if the parent or other legal guardian is illiterate.
• Subject and parent/ legally acceptable representative able to attend the scheduled visits and to comply with all trial procedures.
• Receipt of primary vaccination with 3 doses of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B and a booster dose of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™+ OPV.

You may not qualify if:

• Incomplete primary and booster immunization at trial A3L15.
• Previous confirmed clinical, serological, or microbiological diagnosis of diphtheria, tetanus, whooping cough, poliomyelitis, Haemophilus influenza b or hepatitis B after completion of A3L15 Study.
• Subjects known to have received diphtheria, tetanus, pertussis, Haemophilus influenza b and hepatitis B vaccination after completion of A3L15 Study.
• Known or suspected congenital or acquired immunodeficiency since completion of A3L15 Study.
• Serious chronic illness occurring after receipt of the primary and booster series (e.g. leukemia, lymphoma \[Tor B cells\], Crohn's disease).
• Known or suspected subject seroconversion for human immunodeficiency virus (HIV) or hepatitis C seropositivity since completion of A3L15 Study.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Unknown Facility

Bertsham, 2013, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

ZA (2)