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

NCT ID: NCT01177722

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-12-31

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.

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

DTaP-IPV-Hep B-PRP-T Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

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

Group Type: EXPERIMENTAL

DTaP-IPV-Hep B-PRP-T Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

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

Group Type: EXPERIMENTAL

DTaP-IPV-Hep B-PRP-T Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Group 4: Active Control

Group Type: ACTIVE_COMPARATOR

DTaP-Hep B-IPV vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

DTaP-IPV-Hep B-PRP-T Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

DTaP-IPV-Hep B-PRP-T Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

DTaP-IPV-Hep B-PRP-T Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

DTaP-Hep B-IPV vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Infanrix hexa™

Eligibility Criteria

Inclusion Criteria

• Two month old infants (55 to 65 days old) on the day of inclusion.
• 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.

Exclusion Criteria

• 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.
• Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination.
• History of seizures or encephalopathy.
• Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.

• Minimum Eligible Age: 55 Days
• Maximum Eligible Age: 65 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Cali, , Colombia

San José, , Costa Rica

Countries

Colombia; Costa Rica

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

UTN: U1111-1111-5801

Identifier Type: OTHER

Identifier Source: secondary_id

A3L24

Identifier Type: -

Identifier Source: org_study_id