Trial Outcomes & Findings for Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule (NCT NCT00289744)
NCT ID: NCT00289744
Last Updated: 2018-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
178 participants
Primary outcome timeframe
Years 6, 7, 8, 9, and 10.
Results posted on
2018-08-20
Participant Flow
All subjects enrolled in the primary study (208127/076) were invited to come back for the long-term follow-up visits at Year 6 to 10. The enrollment in the protocol section reflects the amount of subjects who came back at year 6. At follow up timepoints less subjects came back.
25 subjects lost seroprotective concentrations for anti-HBs antibodies at blood sampling time-points Years 6 to 10 and were offered an additional dose of Engerix™-B after Year 10 (additional dose phase). These subjects are presented in separate sub-groups for analysis purposes while as per study protocol, the single experimental group is Twinrix.
Participant milestones
| Measure |
Twinrix Group
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Adult)
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
|
Engerix-B Additional Dose (Pediatric)
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|---|
|
Year 6 Long-term Follow-up
STARTED
|
178
|
0
|
0
|
|
Year 6 Long-term Follow-up
COMPLETED
|
178
|
0
|
0
|
|
Year 6 Long-term Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 7 Long-term Follow-up
STARTED
|
175
|
0
|
0
|
|
Year 7 Long-term Follow-up
COMPLETED
|
175
|
0
|
0
|
|
Year 7 Long-term Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 8 Long-term Follow-up
STARTED
|
174
|
0
|
0
|
|
Year 8 Long-term Follow-up
COMPLETED
|
174
|
0
|
0
|
|
Year 8 Long-term Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 9 Long-term Follow-up
STARTED
|
173
|
0
|
0
|
|
Year 9 Long-term Follow-up
COMPLETED
|
173
|
0
|
0
|
|
Year 9 Long-term Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 10 Long-term Follow-up
STARTED
|
171
|
0
|
0
|
|
Year 10 Long-term Follow-up
COMPLETED
|
171
|
0
|
0
|
|
Year 10 Long-term Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
|
Additional Dose Phase
STARTED
|
0
|
19
|
6
|
|
Additional Dose Phase
COMPLETED
|
0
|
19
|
6
|
|
Additional Dose Phase
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
Baseline characteristics by cohort
| Measure |
Twinrix Group
n=178 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
|---|---|
|
Age, Continuous
|
13.1 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Years 6, 7, 8, 9, and 10.Population: The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity.
Outcome measures
| Measure |
Twinrix Group
n=142 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Year 6 (n=142)
|
692.3 milli-international units per milliliter
Interval 600.9 to 797.5
|
—
|
|
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Year 7 (n=136)
|
753.6 milli-international units per milliliter
Interval 650.2 to 873.5
|
—
|
|
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Year 8 (n=132)
|
544.4 milli-international units per milliliter
Interval 476.9 to 621.4
|
—
|
|
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Year 9 (n=121)
|
479.5 milli-international units per milliliter
Interval 413.3 to 556.3
|
—
|
|
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Year 10 (n=120)
|
601.6 milli-international units per milliliter
Interval 510.6 to 708.8
|
—
|
PRIMARY outcome
Timeframe: At Year 6, 7, 8, 9 and 10Population: The analysis was performed on the long-term (LT) according to protocol (ATP) cohort for immunogenicity.
Outcome measures
| Measure |
Twinrix Group
n=142 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Year 6 (n= 142)
|
206.2 milli-international units per milliliter
Interval 149.3 to 284.8
|
—
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Year 7 (n= 136)
|
157.5 milli-international units per milliliter
Interval 113.7 to 218.4
|
—
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Year 8 (n= 132)
|
102.7 milli-international units per milliliter
Interval 74.7 to 141.1
|
—
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Year 9 (n = 121)
|
89.1 milli-international units per milliliter
Interval 64.9 to 122.5
|
—
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Year 10 (n= 120)
|
80.7 milli-international units per milliliter
Interval 58.1 to 112.0
|
—
|
PRIMARY outcome
Timeframe: Before and 1 month after the additional dose administrationPopulation: The analysis was performed on the total vaccinated cohort for the additional dose.
Outcome measures
| Measure |
Twinrix Group
n=19 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
n=6 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Pre-vaccination
|
10.4 milli-international units per milliliter
Interval 8.0 to 13.5
|
8.7 milli-international units per milliliter
Interval 3.3 to 23.0
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
1 month after vaccination
|
1431.9 milli-international units per milliliter
Interval 730.2 to 2807.9
|
565.9 milli-international units per milliliter
Interval 163.9 to 1953.5
|
PRIMARY outcome
Timeframe: One month after the additional dose administrationPopulation: The analysis was performed on the total vaccinated cohort for the additional dose.
Immune response was defined as: * anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points * at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.
Outcome measures
| Measure |
Twinrix Group
n=19 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
n=6 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
|
19 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: At Year 6, 7, 8, 9 and 10Population: The analysis was performed on the long-term (LT) total vaccinated cohort.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Twinrix Group
n=178 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Year 6 (n= 178)
|
0 Participants
|
—
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Year 7 (n= 175)
|
0 Participants
|
—
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Year 8 (n= 174)
|
0 Participants
|
—
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Year 9 (n= 173)
|
0 Participants
|
—
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Year 10 (n= 171)
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During the 4-day follow-up period after additional dosePopulation: The analysis was performed on the total vaccinated cohort for the additional dose.
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Outcome measures
| Measure |
Twinrix Group
n=19 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
n=6 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Pain
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Redness
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Swelling
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fatigue
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Gastrointestinal symptoms
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Headache
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 30-day follow-up period after additional dosePopulation: The analysis was performed on the total vaccinated cohort for the additional dose.
Unsolicited adverse event (AE) covers any AE 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.
Outcome measures
| Measure |
Twinrix Group
n=19 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
n=6 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 30-day follow-up period after additional dosePopulation: The analysis was performed on the total vaccinated cohort for the additional dose.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Twinrix Group
n=19 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
n=6 Participants
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Engerix-B Additional Dose (Adult)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Twinrix Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Engerix-B Additional Dose (Pediatric)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Engerix-B Additional Dose (Adult)
n=19 participants at risk
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
|
Twinrix Group
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
|
Engerix-B Additional Dose (Pediatric)
n=6 participants at risk
Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
|
|---|---|---|---|
|
General disorders
Pain
|
31.6%
6/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
50.0%
3/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
General disorders
Redness
|
10.5%
2/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
16.7%
1/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
General disorders
Swelling
|
5.3%
1/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
0.00%
0/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
General disorders
Fatigue
|
10.5%
2/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
50.0%
3/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
General disorders
Fever
|
0.00%
0/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
16.7%
1/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
General disorders
Gastrointestinal symptoms
|
10.5%
2/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
16.7%
1/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
General disorders
Headache
|
15.8%
3/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
0.00%
0/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
16.7%
1/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
—
0/0 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
0.00%
0/6 • SAEs: At each time-point of the long-term follow-up period & during the 30-day follow-up period after the additional dose. Other AEs: During the 4-day (solicited AEs) or the 30-day (unsolicited AEs) follow-up period after the additional dose.
Safety results were only collected for those subjects receiving an additional vaccine dose (adult or pediatric)
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER