Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01411241
First received: August 3, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The aim of the study is to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaxim™) during the same day and visit but in 2 different sites of administration.

Primary Objective:

  • To demonstrate the non-inferiority of the antibody response against all antigens (diphtheria, tetanus, pertussis, polio and Hib) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to subjects receiving one booster dose of Pentaxim™ vaccine administered concomitantly with placebo.

Secondary Objectives:

  • To describe the safety of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo.
  • To describe the safety of the CYD dengue vaccine in all subjects after each dose.
  • To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine or administered alone.
  • To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3 in all subjects.

Condition Intervention Phase
Dengue
Dengue Hemorrhagic Fever
Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
Biological: DTaP IPV//Hib vaccine
Biological: Placebo
Biological: Measles, mumps, and rubella vaccine
Biological: Pneumococcal 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: Immunogenicity and Safety of a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers Aged 15 to 18 Months in Mexico

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Information on the antibody to diphtheria toxoid, tetanus toxoid, pertussis, Filamentous haemagglutinin, polyribosylribitol phosphate (PRP) and polio post-Pentaxim booster vaccination [ Time Frame: 28 days post-Pentaxim vaccination ] [ Designated as safety issue: No ]
    Levels of antibodies to diphtheria toxoid, tetanus toxoid, pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate (PRP) and polio antigens will be measured post-Pentaxim booster vaccination.


Secondary Outcome Measures:
  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with Pentaxim and CYD vaccines. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Tenderness, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb; Solicited Systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.

  • Information concerning the immunogenicity of CYD dengue vaccine post-vaccination [ Time Frame: 28 days post-dose 2 and dose 3 ] [ Designated as safety issue: No ]
    Neutralizing antibody levels against each of the 4 dengue virus serotype strains contained in the CYD dengue vaccine will be measured in sera collected from a randomized subset of participants using the dengue plaque reduction neutralization test (PRNT).


Enrollment: 720
Study Start Date: July 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYD Dengue Vaccine Group 1
Participants will receive CYD dengue vaccine dose 1 at age 9 to 12 months, Trimovax® + booster with Prevenar® at 10 to 13 months, Pentaxim™ + CYD dengue vaccine dose 2 at 15 to 18 months, placebo at 16 to 19 months, and CYD dengue vaccine dose 3 at 21 to 24 months.
Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
Other Name: CYD Dengue Vaccine
Biological: DTaP IPV//Hib vaccine
0.5 mL, intramuscular
Other Name: Pentaxim™
Biological: Placebo
0.5 mL, subcutaneous
Other Name: NaCl
Biological: Measles, mumps, and rubella vaccine
0.5 mL, subcutaneous
Other Name: Trimovax®
Biological: Pneumococcal vaccine
0.5 mL, intramuscular
Other Name: Prevenar®
Experimental: CYD Dengue Vaccine Group 2
Participants will receive CYD dengue vaccine dose 1 at age 9 to 12 months, Trimovax® + booster with Prevenar® at 10 to 13 months, Pentaxim™ + placebo at 15 to 18 months, CYD dengue vaccine dose 2 at 16 to 19 months, and CYD dengue vaccine dose 3 at 21 to 24 months.
Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus
0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months
Other Name: CYD Dengue Vaccine
Biological: DTaP IPV//Hib vaccine
0.5 mL, intramuscular
Other Name: Pentaxim™
Biological: Placebo
0.5 mL, subcutaneously
Other Name: NaCl
Biological: Measles, mumps, and rubella vaccine
0.5 mL, subcutaneous
Other Name: Trimovax®
Biological: Pneumococcal vaccine
0.5 mL, intramuscular
Other Name: Prevenar®

Detailed Description:

Participants will require 8 or 9 clinic visits and will receive a total of 7 injections. The dengue post-vaccinal viremia will be assessed at Visit 2 from a subset of toddlers. The dengue immunogenicity will be assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of toddlers. All participants will be followed-up for safety after each vaccine dose and for 6 months after the last dengue vaccination.

  Eligibility

Ages Eligible for Study:   9 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 9 to 12 months on the day of inclusion.
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
  • Subject in good health, based on medical history and physical examination.
  • Documentation of completion of the primary vaccination series with Pentaxim vaccine with the 2-4-6 month regimen ± 2 weeks for each vaccination.
  • Informed consent form has been signed and dated by both parents or other legally acceptable representative (and by 2 mandatory witnesses as required by local regulations).
  • Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
  • Previous vaccination against flavivirus diseases, measles, mumps, rubella, previous booster vaccination against pneumococcal diseases, diphtheria, tetanus, pertussis, Haemophilus influenzae b (Hib) and/or polio.
  • Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Personal seropositivity for human immunodeficiency virus (HIV) or hepatitis C as reported by the parent(s)/legally acceptable representative.
  • History of pertussis and/or Hib infection as reported by the parent(s)/legally acceptable representative.
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances .
  • History of contraindication to the receipt of vaccines containing components of Pentaxim vaccine (diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous hemagglutinin, polyribosylribitol phosphate [PRP] and polio) or of Trimovax (measles, mumps and rubella) vaccine and of Prevenar (pneumococcal) vaccine.
  • Thrombocytopenia, as reported by the parent(s)/legally acceptable representative.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  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: NCT01411241

Locations
Mexico
Acapulco, Guerrero, Mexico, CP 39670
Guadalajara, Jalisco, Mexico, CP 44280
Monterrey, Nuevo Leon, Mexico, CP 64460
Merida, Yucatan, Mexico, CP 97000
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01411241     History of Changes
Other Study ID Numbers: CYD33, U1111-1115-6290
Study First Received: August 3, 2011
Last Updated: April 8, 2014
Health Authority: Mexico: Ministry of Health

Keywords provided by Sanofi:
Dengue
Dengue Hemorrhagic Fever
CYD Dengue Vaccines
Pentaxim™

Additional relevant MeSH terms:
Dengue
Fever
Severe Dengue
Hemorrhagic Fevers, Viral
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014