Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam

Infections, Streptococcal Clinical Trial

Official title:

Primary Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, in Healthy Infants in Vietnam When Co-administered With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153841
• Other study ID #: 113151
• Secondary ID: 2012-000162-38
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2011
• Est. completion date: July 26, 2011

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 26, 2011
• Est. primary completion date: July 26, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

• Written and signed or thumb-printed informed consent obtained from the parent(s)/LAR of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.

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

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• 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.

• Acute disease and/or fever at the time of enrolment.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).

• History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.

• Hypersensitivity to latex.

• Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.

Related Conditions & MeSH terms

• Infections, Streptococcal
• Pneumonia
• Streptococcal Infections
• Streptococcus Pneumoniae Vaccines

Intervention

Biological:
• Synflorix™( GSK1024850A)
Intramuscular, 3 doses
• Infanrix hexa™
Intramuscular, 3 doses

Locations

Country	Name	City	State
Vietnam	GSK Investigational Site	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

Huu TN, Toan NT, Tuan HM, Viet HL, Le Thanh Binh P, Yu TW, Shafi F, Habib A, Borys D. Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial. BMC Infect Dis. 2013 Feb 21;13:95. doi: 10.1186/1471-2334-13-95. — View Citation

Tran NH et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. Abstract presented at the ICID, Bangkok, Thailand, June 13-16, 2012.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)	The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.	Within the 31-day (Days 0-30) after each dose and across doses
Secondary	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.	During the 4-day (Days 0-3) post-vaccination period following each dose
Secondary	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms	Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature = 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.	During the 4-day (Days 0-3) post-vaccination period following each dose
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited AE is 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.	During the 31-day (Days 0-30) follow-up period after each dose
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	After the first vaccination up to study end (From Month 0 to Month 3)

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