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

Phase 3

Completed

• Conditions: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis
• Interventions: Biological: DTaP-IPV-Hep B-PRP-T Vaccine; Biological: DTaP-Hep B-IPV vaccine

• Registration Number: NCT01177722
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age.

All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Results First Submitted: 2014-02-22
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-03
• Last Update Submitted: 2014-04-03
• Results First Posted: 2014-05-05
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1375

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)	DTaP-IPV-Hep B-PRP-T Vaccine	-
Group 2: DTaP-IPV-Hep B-PRP-T (Lot B)	DTaP-IPV-Hep B-PRP-T Vaccine	-
Group 3: DTaP-IPV-Hep B-PRP-T (Lot C)	DTaP-IPV-Hep B-PRP-T Vaccine	-
Group 4: Active Control	DTaP-Hep B-IPV vaccine	-

Primary Outcome Measures

Name	Time	Method
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™	Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination	Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	30 Days post-dose 3	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).

Secondary Outcome Measures

Name	Time	Method
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	Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).
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	Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
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	Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.