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

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ClinicalTrials.gov Identifier: NCT01177722
Recruitment Status : Completed
First Posted : August 9, 2010
Results First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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™
Study Start Date : August 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
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™


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.

  2. 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 ]
    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 :
  1. 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 ]
    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).

  2. 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 ]
    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.

  3. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   55 Days to 65 Days   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177722


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

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01177722    
Other Study ID Numbers: A3L24
UTN: U1111-1111-5801 ( Other Identifier: WHO )
First Posted: August 9, 2010    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: May 5, 2014
Last Verified: April 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Whooping cough
 Hepatitis B
Poliomyelitis
Diphtheria-Tetanus-acellular Pertussis Vaccines
Additional relevant MeSH terms:
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Hepatitis B
Tetanus
Diphtheria
Poliomyelitis
Whooping Cough
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
 Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Nervous System Diseases
Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases