Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00325143
Other study ID # 217744/100
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 1, 2003
Est. completion date February 1, 2007

Study information

Verified date May 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Description:

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study.


Recruitment information / eligibility

Status Completed
Enrollment 702
Est. completion date February 1, 2007
Est. primary completion date February 1, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Weeks to 17 Weeks
Eligibility Inclusion criteria

- Subjects must have been enrolled in the Rota-028 study.

- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.

- A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.

- Written informed consent obtained from the parent or guardian of the subject.

- Free of obvious health problems as established by medical history and clinical examination before entering into the study.

- Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.

Exclusion criteria

- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.

- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

- A family history of congenital or hereditary immunodeficiency.

- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at the time of enrolment.

- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Study Design


Intervention

Biological:
DTPa-HBV-IPV/Hib
1 intramuscular injection (3rd study vaccine dose)
DTPa-IPV/Hib vaccine
3 intramuscular injections (1st, 2nd and 4th vaccine dose)

Locations

Country Name City State
Singapore GSK Investigational Site Singapore
Singapore GSK Investigational Site Singapore
Singapore GSK Investigational Site Singapore

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Lim FS, Phua KB, Lee BW, Quak SH, Teoh YL, Ramakrishnan G, Han HH, Van Der Meeren O, Jacquets JM, Bock HL. Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 2011 Jan;42(1):138-47. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Reporting Any Solicited Local Symptoms Assessed solicited local and general symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Primary Number of Subjects Reporting Any Solicited General Symptoms Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Secondary Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. During the 31-day (Days 0-30) post-vaccination period
Secondary Number of Subjects Reporting Any Large Swelling Reactions A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference. At Month 15, post-booster dose
Secondary Number of Subjects Reporting Any Serious Adverse Events (SAEs) Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. During the entire study period (from Month 0 up to Month 21)
See also
  Status Clinical Trial Phase
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Completed NCT02538211 - The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01689324 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Phase 1/Phase 2
Completed NCT01444781 - Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Phase 3
Completed NCT01214889 - Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Phase 3
Completed NCT00804284 - Database Surveillance Safety Study of PENTACEL® Vaccine N/A
Completed NCT00514709 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Phase 3
Completed NCT00534833 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ Phase 3
Completed NCT00379977 - Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age Phase 3
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT00879827 - Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants Phase 3
Completed NCT01457495 - Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly Phase 2
Completed NCT01267058 - Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Phase 3
Completed NCT02853929 - Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery Phase 4
Completed NCT02858440 - A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Phase 3
Recruiting NCT06049940 - Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population Phase 3
Completed NCT00385255 - Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults Phase 3