Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children

Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.

• Tritanrix-HepB/Hib-MenAC (Biological): Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
• Tritanrix-HepB/Hiberix (Biological): Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
• Mencevax-ACWY (Biological): Meningococcal Serogroups A, C, W-135 and Y Vaccine

Primary outcomes

• Number of Subjects With Fever >39°C (Rectal Route). [During the 4-day (Day 0-3) follow-up period after booster vaccination]: Among solicited general symptoms fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )\] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C.

Secondary outcomes

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C [During the 4-day (Day 0-3) follow-up period after vaccination]: Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
• Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [During the 4-day (Day 0-3) follow-up period after booster vaccination]: Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
• Number of Subjects With Any Unsolicited Adverse Events (AEs). [During the 31-day (Day 0-30) following booster vaccination]: 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.
• Number of Subjects With Serious Adverse Events (SAEs). [From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination]: 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.

Sex: All, ages: 427 Days to 577 Days, accepts healthy volunteers

Inclusion Criteria:

* Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
* Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
* Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.

Participant flow

Outcome results

• Number of Subjects With Fever >39°C (Rectal Route). (Primary), Count of participants, Participants: ACAC_Thailand Group 22; ACHibPS_Thailand Group 8; HibACPS_Thailand Group 5; HibHibPS_Thailand Group 3; ACAC_Philippines Group 40; ACHibPS_Philippines Group 24; HibACPS_Philippines Group 17; HibHibPS_Philippines Group 6
• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C (Secondary), Count of participants, Participants: ACAC_Thailand Group 113; ACHibPS_Thailand Group 63; HibACPS_Thailand Group 41; HibHibPS_Thailand Group 17; ACAC_Philippines Group 53; ACHibPS_Philippines Group 33; HibACPS_Philippines Group 23; HibHibPS_Philippines Group 8
• Number of Subjects With Any and Grade 3 Solicited Local Symptoms. (Secondary), Number, Subjects: ACAC_Thailand Group 168; ACHibPS_Thailand Group 78; HibACPS_Thailand Group 55; HibHibPS_Thailand Group 26; ACAC_Philippines Group 151; ACHibPS_Philippines Group 69; HibACPS_Philippines Group 49; HibHibPS_Philippines Group 22
• Number of Subjects With Any Unsolicited Adverse Events (AEs). (Secondary), Number, Subjects: ACAC_Thailand Group 64; ACHibPS_Thailand Group 23; HibACPS_Thailand Group 24; HibHibPS_Thailand Group 9; ACAC_Philippines Group 53; ACHibPS_Philippines Group 33; HibACPS_Philippines Group 16; HibHibPS_Philippines Group 6
• Number of Subjects With Serious Adverse Events (SAEs). (Secondary), Number, Subjects: ACAC_Thailand Group 3; ACHibPS_Thailand Group 0; HibACPS_Thailand Group 0; HibHibPS_Thailand Group 0; ACAC_Philippines Group 2; ACHibPS_Philippines Group 1; HibACPS_Philippines Group 0; HibHibPS_Philippines Group 0

Adverse events

Time frame: Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)

Serious adverse events by term

Other adverse events by term

• GSK Clinical Trials, Study director, GlaxoSmithKline