Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01411241
First received: August 3, 2011
Last updated: February 5, 2013
Last verified: February 2013
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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:
MedlinePlus related topics:
Dengue
Diphtheria
Fever
Hemorrhagic Fevers
Measles
Mumps
Rubella
Tetanus
Drug Information available for:
Heptavalent pneumococcal conjugate vaccine
Measles-Mumps-Rubella Vaccine
Pneumococcal Vaccines
U.S. FDA Resources
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).
| Estimated Enrollment: | 732 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | May 2013 (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
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
Investigators
| Study Director: | Medical Director | Sanofi Pasteur SA |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01411241 History of Changes |
| Other Study ID Numbers: | CYD33, U1111-1115-6290 |
| Study First Received: | August 3, 2011 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Mexico: Ministry of Health |
Keywords provided by Sanofi:
|
Dengue Dengue Hemorrhagic Fever CYD Dengue Vaccines Pentaxim™ |
Additional relevant MeSH terms:
|
Dengue Fever Dengue Hemorrhagic Fever 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 May 16, 2013