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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01177722
First received: August 6, 2010
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention Phase
Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Biological: DTaP-Hep B-IPV vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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™ [ Time Frame: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 Days post-dose 3 ] [ Designated as safety issue: No ]
    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:
  • Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine [ Time Frame: Day 0 (pre-vaccination) and 30 days post-dose 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 up to 7 after each dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 up to 7 post each vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 1375
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: DTaP-IPV-Hep B-PRP-T (Lot A) Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
Experimental: Group 2: DTaP-IPV-Hep B-PRP-T (Lot B) Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
Experimental: Group 3: DTaP-IPV-Hep B-PRP-T (Lot C) Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
Active Comparator: Group 4: Active Control Biological: DTaP-Hep B-IPV vaccine
0.5 mL, Intramuscular
Other Name: Infanrix hexa™

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.

  Eligibility

Ages Eligible for Study:   55 Days to 65 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177722

Locations
Colombia
Cali, Colombia
Costa Rica
San José de Costa Rica, Costa Rica
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01177722     History of Changes
Other Study ID Numbers: A3L24, UTN: U1111-1111-5801
Study First Received: August 6, 2010
Results First Received: February 22, 2014
Last Updated: April 3, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Costa Rica: Ministry of Health Costa Rica

Keywords provided by Sanofi:
Diphtheria
Tetanus
Whooping cough
Hepatitis B
Poliomyelitis
Diphtheria-Tetanus-acellular Pertussis Vaccines

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis B
Poliomyelitis
Whooping Cough
Actinomycetales Infections
Bacterial Infections
Bordetella Infections
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Corynebacterium Infections
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Infection
Liver Diseases
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014