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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Dengue Hemorrhagic Fever

Dengue

Treatments

Biological: Pneumococcal vaccine

Biological: Measles, mumps, and rubella vaccine

Biological: Placebo

Biological: DTaP IPV//Hib vaccine

Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01411241

CYD33

U1111-1115-6290 (Other Identifier)

Details and patient eligibility

About

The aim of the study was 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 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 Haemophilus influenzae type b (Hib)) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to participants 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 after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim™ vaccine (at Visit 05) or administered alone (at Visit 06).
To describe the safety of the CYD dengue vaccine in all participants 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 (at Visit 05) or administered alone (at Visit 06).
To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3.

Full description

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

Enrollment

720 patients

Sex

All

Ages

9 to 12 months old

Volunteers

Accepts Healthy Volunteers

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.
Participant in good health, based on medical history and physical examination.
Documentation of completion of the primary vaccination series with Pentaxim vaccine with the 3 doses received between 2 and 8 months of age.
Informed consent form had been signed and dated by both parents or other legally acceptable representative (and by 2 mandatory witnesses as required by local regulations).
Participant and parent/guardian attended all scheduled visits and 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, 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 measles, mumps and rubella vaccine and of 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.
History of central nervous system disorder or disease, including seizures.
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

720 participants in 2 patient groups

CYD Dengue Vaccine Group 1

Experimental group

Description:

Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).

Treatment:

Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus

Biological: DTaP IPV//Hib vaccine

Biological: Measles, mumps, and rubella vaccine

Biological: Pneumococcal vaccine

Biological: Measles, mumps, and rubella vaccine

Biological: Placebo

Biological: Pneumococcal vaccine

Biological: DTaP IPV//Hib vaccine

Biological: Placebo

CYD Dengue Vaccine Group 2

Experimental group

Description:

Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).

Treatment:

Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus

Biological: DTaP IPV//Hib vaccine

Biological: Measles, mumps, and rubella vaccine

Biological: Pneumococcal vaccine

Biological: Measles, mumps, and rubella vaccine

Biological: Placebo

Biological: Pneumococcal vaccine

Biological: DTaP IPV//Hib vaccine

Biological: Placebo