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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Infanrix Hexa and Rotarix

NCT00533507•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Taiwanese infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine and rotavirus vaccine in children during the first 6 months of life.

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female subjects between, and including 6-8 weeks of age at the time of the first vaccination.
•Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
•Written informed consent obtained from the parent(s) or guardian(s) of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
•A family history of congenital or hereditary immunodeficiency.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae; with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (e.g. Hepatitis B and Bacillus Calmette-Guérin (BCG)).
•History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
•Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
+5 more criteria

Locations (3)

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Taoyuan Hsien, Taiwan

Key Dates

Start Date

September 18, 2007

Primary Completion Date

June 1, 2008

Completion Date

June 6, 2008

Last Updated

June 8, 2018

Enrollment

230

ACTUAL participants

Conditions

Infections, Rotavirus

Interventions

Synflorix

BIOLOGICAL

Infanrix hexa

BIOLOGICAL

Rotarix

BIOLOGICAL

Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

NCT00480324

Infections, RotavirusRotavirus Vaccines

View study

COMPLETED

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

NCT01563159

Infections, Rotavirus

View study

COMPLETEDPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

Inclusion Criteria

Exclusion Criteria

Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines

Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

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Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis