Trial Outcomes & Findings for Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210) (NCT NCT00329745)

Last Updated: 2016-12-09

Results Overview

Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample. Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

8687 participants

Primary outcome timeframe

From Year 2 up to Year 3

Results posted on

2016-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Rotarix Group During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.	Placebo Group During the primary study (NCT00197210) subjects received two oral doses of placebo.
Overall Study STARTED	4359	4328
Overall Study COMPLETED	4272	4226
Overall Study NOT COMPLETED	87	102

Reasons for withdrawal

Reasons for withdrawal
Measure	Rotarix Group During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.	Placebo Group During the primary study (NCT00197210) subjects received two oral doses of placebo.
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	86	101

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotarix Group n=4359 Participants During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.	Placebo Group n=4328 Participants During the primary study (NCT00197210) subjects received two oral doses of placebo.	Total n=8687 Participants Total of all reporting groups
Age, Continuous	35.4 months STANDARD_DEVIATION 1.18 • n=5 Participants	35.4 months STANDARD_DEVIATION 1.26 • n=7 Participants	35.4 months STANDARD_DEVIATION 1.22 • n=5 Participants
Gender Female	2108 Participants n=5 Participants	2097 Participants n=7 Participants	4205 Participants n=5 Participants
Gender Male	2251 Participants n=5 Participants	2231 Participants n=7 Participants	4482 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Year 2 up to Year 3

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy.

Outcome measures

Outcome measures
Measure	Placebo Group n=4185 Participants During the primary study (NCT00197210) subjects received two oral doses of placebo.	Rotarix Group n=4222 Participants During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains	13 subjects	0 subjects

SECONDARY outcome

Timeframe: From the end of the primary study up to Year 3

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Placebo Group n=4328 Participants During the primary study (NCT00197210) subjects received two oral doses of placebo.	Rotarix Group n=4359 Participants During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
Number of Subjects Reporting Serious Adverse Events (SAEs)	11 subjects	10 subjects

Adverse Events

Rotarix Group

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

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

Measure	Rotarix Group n=4359 participants at risk During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.	Placebo Group n=4328 participants at risk During the primary study (NCT00197210) subjects received two oral doses of placebo.
Infections and infestations Gastroenteritis	0.07% 3/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.05% 2/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Gastrointestinal disorders Intussusception	0.05% 2/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Infections and infestations Upper respiratory tract	0.00% 0/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.07% 3/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Gastrointestinal disorders Gastritis	0.02% 1/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.00% 0/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.05% 2/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Blood and lymphatic system disorders Lymphadenitis	0.02% 1/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Injury, poisoning and procedural complications Burns third degree	0.02% 1/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.00% 0/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Injury, poisoning and procedural complications Croup infectious	0.00% 0/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Metabolism and nutrition disorders Dehydratation	0.00% 0/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.02% 1/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.00% 0/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Infections and infestations Epyema	0.00% 0/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Nervous system disorders Febrile convulsion	0.02% 1/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.00% 0/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Infections and infestations Kawasaki's disease	0.02% 1/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.00% 0/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.
Injury, poisoning and procedural complications Overdose	0.00% 0/4359 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.	0.02% 1/4328 Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.