A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

NCT01177722 | Completed Phase 3 Results DMC

• 2 other identifiers: A3L24UTN: U1111-1111-5801
• Study Type: interventional
• Target: 1,375
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines. Primary Objectives:

• To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
• To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™. Secondary Objectives:
• To describe in each group the immunogenicity parameters for all antigens for each vaccine
• To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

Conditions

Tetanus; Diphtheria; Whooping Cough; Hepatitis B; Poliomyelitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™

  Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.

  Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination

• Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

  Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).

  30 Days post-dose 3

Secondary Outcomes (3)

• Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

  Day 0 (pre-vaccination) and 30 days post-dose 3

• Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

  Day 0 up to 7 after each dose

• Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine

  Day 0 up to 7 post each vaccination

Study Arms (4)

Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)

EXPERIMENTAL

Biological: DTaP-IPV-Hep B-PRP-T Vaccine

Group 2: DTaP-IPV-Hep B-PRP-T (Lot B)

EXPERIMENTAL

Biological: DTaP-IPV-Hep B-PRP-T Vaccine

Group 3: DTaP-IPV-Hep B-PRP-T (Lot C)

EXPERIMENTAL

Biological: DTaP-IPV-Hep B-PRP-T Vaccine

Group 4: Active Control

ACTIVE COMPARATOR

Biological: DTaP-Hep B-IPV vaccine

Interventions

DTaP-IPV-Hep B-PRP-T Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)

DTaP-Hep B-IPV vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Infanrix hexa™

Group 4: Active Control

Eligibility Criteria

• Age: 55 Days - 65 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
• Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements.
• Able to attend all scheduled visits and to comply with all trial procedures.
• Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.

You may not qualify if:

• Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
• Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
• Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth).
• Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines).
• Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
• Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
• Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
• History of seizures or encephalopathy.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Cali, Colombia

Location

Unknown Facility

San José, Costa Rica

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

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

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 9, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 5, 2014
• Results First Posted: May 5, 2014

Record last verified: 2014-04

Locations

CO (1)