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Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar

Primary Purpose

Streptococcus Pneumoniae

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Pneumo 23

Prevnar

About this trial

This is an interventional prevention trial for Streptococcus Pneumoniae focused on measuring Streptococcus pneumoniae

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 12 to 18 months on the day of inclusion
Informed consent form signed by the parent/legally acceptable representative and by an independent witness if requested by local Ethics Committee regulation or/and if the parent/legally acceptable representative is illiterate
Child having completed the three-dose primary vaccination of Prevnar® in the hexavalent combined vaccine study (study A3L12).
Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures

Exclusion Criteria:

Participation in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination
Planned participation in another clinical study during the present study period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or to a vaccine containing any of the same substances
Chronic illness at a stage that could interfere with study conduct or completion, in the opinion of the investigator
Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
Receipt of any vaccine in the 4 weeks preceding the study vaccination
Planned receipt of any vaccine in the 4 weeks preceding or following study vaccination
History of seizures Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) antigen or Hepatitis C seropositivity
History of pneumococcal infection (confirmed either clinically, serologically or microbiologically)
Previous booster vaccination against the pneumococcal disease with either the study vaccine(s) or another vaccine
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Pneumo 23

Prevnar

Outcomes

Primary Outcome Measures

To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine

Secondary Outcome Measures

Full Information

NCT ID

NCT00594347

First Posted

December 19, 2007

Last Updated

June 16, 2015

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00594347

Brief Title

Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar

Official Title

Immunogenicity and Safety of a Booster Dose of Polysaccharide Pneumococcal Vaccine (Pneumo 23®) in 12 to 18 Months-Old Children Primed With Three Doses of Pneumococcal Conjugate Vaccine (Prevnar®) in Thailand.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The present study intends to investigate the use as a booster of a dose of sanofi pasteur's Pneumo 23 vaccine in the second year of life following 3-dose priming with Wyeth's Prevnar vaccine. The researchers will use a cohort of subjects who have received 3 doses of Prevnar® at 2, 4, 6 months of age in the context of the clinical study A3L12 on Hexavalent combined vaccine (DTaP-IPV-HB-PRP~T)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Streptococcus Pneumoniae

Keywords

Streptococcus pneumoniae

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

339 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Pneumo 23

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Prevnar

Intervention Type

Biological

Intervention Name(s)

Pneumo 23

Intervention Description

Vaccine (Pneumo 23)

Intervention Type

Biological

Intervention Name(s)

Prevnar

Intervention Description

Vaccine (Prevnar)

Primary Outcome Measure Information:

Title

To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine

Time Frame

30 days post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

18 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 12 to 18 months on the day of inclusion Informed consent form signed by the parent/legally acceptable representative and by an independent witness if requested by local Ethics Committee regulation or/and if the parent/legally acceptable representative is illiterate Child having completed the three-dose primary vaccination of Prevnar® in the hexavalent combined vaccine study (study A3L12). Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures Exclusion Criteria: Participation in another clinical study investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the study vaccination Planned participation in another clinical study during the present study period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or to a vaccine containing any of the same substances Chronic illness at a stage that could interfere with study conduct or completion, in the opinion of the investigator Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response Receipt of any vaccine in the 4 weeks preceding the study vaccination Planned receipt of any vaccine in the 4 weeks preceding or following study vaccination History of seizures Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) antigen or Hepatitis C seropositivity History of pneumococcal infection (confirmed either clinically, serologically or microbiologically) Previous booster vaccination against the pneumococcal disease with either the study vaccine(s) or another vaccine Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Bangkok

Country

Thailand

City

KhonKaen

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

25424793

Citation

Thisyakorn U, Chokephaibulkit K, Kosalaraksa P, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S. Immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine as a booster dose in 12- to 18-month-old children primed with 3 doses of 7-valent pneumococcal conjugate vaccine. Hum Vaccin Immunother. 2014;10(7):1859-65. doi: 10.4161/hv.28642.

Results Reference

result

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

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Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar

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