Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

NCT00362336 | Completed Phase 3 Results DMC

• 1 other identifier: A3L15
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth. The secondary Objectives are: To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial. To describe Immunogenicity after the primary series and prior to and after a booster vaccination.

Conditions

Hepatitis B; Polio; Diphtheria; Pertussis; Haemophilus Influenzae Type b

Keywords

Hepatitis B; Polio; Diphtheria; Pertussis; H. influenzae type b

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

  Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).

  1 month post-Dose 3

Secondary Outcomes (6)

• Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

  1 month post-Dose 3

• Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)

  Day 42 before Dose 1 and 1 month post-Dose 3

• Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV

  Day 540 pre-booster and Day 570 post-booster

• Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV

  Day 540 pre-booster and Day 570, post-booster

• Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).

  Day 0 up to Day 7 post each dose

Study Arms (3)

Group 1: DTaP-IPV-Hep B-PRP-T

EXPERIMENTAL

Biological: DTaP-IPV-HB-PRP~T

Group 2: CombAct-HIB™ + OPV

EXPERIMENTAL

Biological: CombAct-HIB®

Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth)

ACTIVE COMPARATOR

Biological: Engerix B® Pediatric

Interventions

DTaP-IPV-HB-PRP~T BIOLOGICAL

0.5 mL, Intramuscular (IM)

Group 1: DTaP-IPV-Hep B-PRP-T

CombAct-HIB® BIOLOGICAL

0.5 mL, IM

Group 2: CombAct-HIB™ + OPV

Engerix B® Pediatric BIOLOGICAL

0.5 mL, IM

Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth)

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 3 day old infants
• Mother seronegative for Human Immunodeficiency Virus (HIV)
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Apgar score \>7 at 5 or 10 minutes of life
• Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• Current or planned participation in another clinical trial during the entire duration of the present trial
• Suspected congenital or acquired immunodeficiency
• Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
• Chronic illness at a stage that could interfere with trial conduct or completion
• Blood or blood-derived products received since birth
• Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age
• Oral Poliovirus Vaccine (OPV) administration at birth
• Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity
• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
• History of seizures

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Soweto, Johannesburg, 2013, South Africa

Location

Unknown Facility

Bertsham, South Africa

Location

Related Publications (1)

• Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74. doi: 10.1097/INF.0b013e31820b93d2.

  PMID: 21289531 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis B; Poliomyelitis; Diphtheria; Whooping Cough; Haemophilus Infections

Interventions

DTaP-IPV-HB-PRP-T vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; 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; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pasteurellaceae Infections

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Clinical Trials

  Sanofi Pasteur Inc.

  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: August 8, 2006
• First Posted: August 10, 2006
• Study Start: August 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: August 1, 2009
• Last Updated: May 2, 2014
• Results First Posted: May 2, 2014

Record last verified: 2014-04

Locations

ZA (2)