Rotavirus Efficacy and Safety Trial (REST)(V260-006) | NCT00090233

ID	Type	Description	Link
2004_012

Rotavirus Efficacy and Safety Trial (REST)(V260-006) | NCT00090233 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental	RotaTeq	Biological: Rotateq™
2	Placebo Comparator	Placebo	Biological: Comparator: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rotateq™	Biological	3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo	Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.	Within 42 days following any dose of RotaTeq™/placebo
Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination	Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.	At least 14 days following the 3rd vaccination through the first full rotavirus season

Secondary Outcomes

Measure	Description	Time Frame
G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus	Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.	14 days following the 3rd vaccination
Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16394299	Result	Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, Shinefield HR, Christie CD, Ylitalo S, Itzler RF, Coia ML, Onorato MT, Adeyi BA, Marshall GS, Gothefors L, Campens D, Karvonen A, Watt JP, O'Brien KL, DiNubile MJ, Clark HF, Boslego JW, Offit PA, Heaton PM; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006 Jan 5;354(1):23-33. doi: 10.1056/NEJMoa052664.
20540778

Arm/Group Information

ID	Title	Description
FG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
FG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00034644 subjectsEvaluated by data safety monitoring board (DSMB) when they recommended stopping enrollment FG00134630 subjectsEvaluated by data safety monitoring board when they recommended stopping enrollment
Vaccinated at Visit 1		FG00034035 subjectsRandomized Not vaccinated 609 FG00134003 subjectsRandomized Not vaccinated 627
Vaccinated at Visit 2		FG00031052 subjects FG00131066 subjects
Vaccinated at Visit 3		FG00029667 subjects FG00129598 subjects
COMPLETED		FG00029645 subjectsDoes not include participants who discontinued prior to the 42 day safety follow-up FG00129565 subjectsDoes not include participants who discontinued prior to the 42 day safety follow-up
NOT COMPLETED		FG0004999 subjects FG0015065 subjects

Type	Comment	Reasons
Randomized Not Vaccinated (Visit 1)		FG000609 subjects FG001627 subjects
Adverse Event		FG000214 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
BG001	Placebo

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized	The eligibility for this study was to enroll infants 6-12 weeks of age; however infants that were 5 weeks and under, and infants who were 12 weeks and over were inadvertently enrolled outside these ranges. Those infants who received at least 1 dose of study vaccine, were followed for safety.

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo

Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.

All participants in the study were followed for potential cases of intussusception.

Posted

Number

Participants

Within 42 days following any dose of RotaTeq™/placebo

ID	Title	Description
OG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
OG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (8.1)	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Conjunctivitis	Eye disorders	MedDRA (8.1)	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Senior Vice President, Global Clinical Development	Merck Sharp & Dohme Corp	1-800-672-6372

Condition Browse Module

ID	Term
D012400	Rotavirus Infections

ID	Term
D012088	Reoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Intervention Browse Module

ID	Term
C492535	RotaTeq
D022243	Rotavirus Vaccines

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Title

Denominators

Categories

5 Weeks of Age and Under

Title	Measurements
	BG0001 BG0014 BG0025

6 to 12 Weeks of Age

Title	Measurements
	BG00034551 BG00134527 BG00269078

Over 12 Weeks of Age

Title	Measurements
	BG00092 BG00199 BG002191

Race/Ethnicity

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG00023772 BG00123788 BG00247560

Hispanic American

Title	Measurements
	BG0004963 BG0014911 BG0029874

Black

Title	Measurements
	BG0002908 BG0012941 BG0025849

Multi Racial

Title	Measurements
	BG0001815 BG0011817 BG0023632

Asian

Title	Measurements
	BG000536 BG001552 BG0021088

Native American

Title	Measurements
	BG000531 BG001514 BG0021045

Other

Title	Measurements
	BG000119 BG001107 BG002226

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Exact binomial test	Exact binomial test adjusted for group-sequential design.	0.006	p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach. Adjusted for group-sequential design.	relative risk	1.6				95	0.4	6.4				Yes	Non-Inferiority or Equivalence	Relative Risk ≤10.0 (non-inferiority margin).

Secondary

G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus

Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.

Per Protocol Population among participants in Finland using Per-Protocol Case Definition

Posted

Number

Participants

14 days following the 3rd vaccination

ID	Title	Description
OG000	RotaTeq™	Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
OG001	Placebo	Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.

Units	Counts
Participants	OG000117 OG00189

Title

Denominators

Categories

Title	Measurements
	OG00095 OG0018

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000		Exact binomial test		<0.001	p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.	Proportion	81.2				95	72.9	87.8				No	Superiority or Other

Primary

Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination

Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.

Per Protocol Population Using Per-Protocol Case Definition

Posted

Number

Participants

At least 14 days following the 3rd vaccination through the first full rotavirus season

ID	Title	Description
OG000	RotaTeq™	The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
OG001	Placebo	The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.

Units	Counts
Participants	OG0002207 OG0012305

Title

Denominators

Categories

Title	Measurements
	OG00082 OG001315

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Exact binomial test	Exact binomial test.	<0.001	Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.	Efficacy=1-Relative Risk	74.0				95	66.8	79.9			Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.	No	Superiority or Other

Secondary

Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4

Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.

Per Protocol Population Using Per-Protocol Case Definition

Posted

Number

Annual # of events per 1000 person-years

At least 14 days following the 3rd vaccination

ID	Title	Description
OG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
OG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

Units	Counts
Participants	OG00028646 OG00128488

Title

Denominators

Categories

Hospital admissions

Title	Measurements
	OG0006 OG001144

Emergency department visits

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Poisson regression	Poisson regression with generalized estimating equations. Validated with Van Elteren's extension of Wilcoxon Rank Sum test.	<0.001	Rate Reduction>0%	Risk Ratio (RR)	94.5				95	91.2	96.6			Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.	No	Superiority or Other

Secondary

Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.

Number of participants with rotavirus gastroenteritis whose clinical score was >8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].

Per Protocol Population Using Per-Protocol Case Definition

Posted

Number

Participants

At least 14 days following the 3rd vaccination through the first rotavirus season

ID	Title	Description
OG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
OG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

Units	Counts
Participants	OG0002201 OG0012292

Title

Denominators

Categories

First episode scores

Title	Measurements
	OG00048 OG001262

Worst episode scores

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Exact binomial test		<0.001	Efficacy>0%. Based on p< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.	Efficacy=1-Relative Risk	81.5				95	74.9	86.7			Estimated value is based on the worst episode scores.	No	Superiority or Other

Secondary

Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose

Number of participants with rotavirus gastroenteritis whose clinical score was >16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].

Per Protocol Population Using Per-Protocol Case Definition

Posted

Number

Participants

At least 14 days following the 3rd vaccination through the first rotavirus season

ID	Title	Description
OG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
OG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

Units	Counts
Participants	OG0002198 OG0012271

Title

Denominators

Categories

First episode scores

Title	Measurements
	OG0001 OG00151

Worst episode scores

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Exact binomial test		<0.001	Efficacy>0%. Based on p< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.	Efficacy=1-Relative Risk	98.0				95	88.3	100				No	Superiority or Other

Secondary

Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo

The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, & polio types 1, 2, & 3, per established criteria.

Per Protocol Population

Posted

Number

Participants

42 days following third dose

ID	Title	Description
OG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
OG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

Units	Counts
Participants	OG000558 OG001592

Title

Denominators

Categories

Hepatitis B (N=202, N=214)

Title	Measurements
	OG000197 OG001203

Haemophilus influenzae type b (N=558, N=592)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Miettenen and Nurminen		<0.001	p<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.						95						Yes	Non-Inferiority or Equivalence	Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).

Secondary

Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin

Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).

Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.

Posted

Geometric Mean

95% Confidence Interval

ELISA units/mL

42 days following third dose

ID	Title	Description
OG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
OG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

Units	Counts
Participants	OG00059 OG00178

Title

Denominators

Categories

Pertussis PT

Title	Measurements
	OG00020.18(17.10 to 23.81) OG00122.73(19.59 to 26.37)

Pertussis FHA

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.	t-test, 1 sided	t-test on natural log of titers	<0.001		GMTR for Pertussis PT	0.9			2-Sided	95	0.7	1.1				Yes	Non-Inferiority or Equivalence	GMTR was greater than 0.5 (non-inferiority margin).

Secondary

Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F

Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.

Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.

Posted

Geometric Mean

95% Confidence Interval

micrograms/mL

42 days following third dose

ID	Title	Description
OG000	RotaTeq™	Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
OG001	Placebo	Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

Units	Counts
Participants	OG000185 OG001198

Title

Denominators

Categories

Pneumococcal serotype 4 (N=181, N=196)

Title	Measurements
	OG0001.13(0.99 to 1.29) OG0010.96(0.84 to 1.09)

Pneumococcal serotype 6B (N=185, N=198)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.	t-test, 1 sided	t-test on natural log of titers	<0.001		GMTR for pneumococcal serotype 4	1.2				95	1.0	1.4				Yes	Non-Inferiority or Equivalence	GMTR was greater than 0.5 (non-inferiority margin).