Trial Outcomes & Findings for Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED) (NCT NCT00130832)

Last Updated: 2015-04-01

Results Overview

GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

735 participants

Primary outcome timeframe

Approximately 42 days Postdose 3

Results posted on

2015-04-01

Participant Flow

Enrollment occurred at 9 study sites in Mexico, Costa Rica, Guatemala, and Brazil from 19-Oct-2005 (first subject in) to 06-Jan-2006 (last subject randomized).

Excluded from randomization were subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive, clinical evidence of active gastrointestinal illness and those with fever, a rectal temperature ≥38.1°C (≥100.5°F) at time of immunization.

Participant milestones

Participant milestones
Measure	RotaTeq and Oral Poliovirus (OPV) Concomitantly Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart	RotaTeq and Oral Poliovirus (OPV) Staggered Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
Overall Study STARTED	372	363
Overall Study COMPLETED	356	346
Overall Study NOT COMPLETED	16	17

Reasons for withdrawal

Reasons for withdrawal
Measure	RotaTeq and Oral Poliovirus (OPV) Concomitantly Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart	RotaTeq and Oral Poliovirus (OPV) Staggered Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	1	2
Overall Study Protocol Violation	6	8
Overall Study Withdrawal by Subject	6	1
Overall Study Moved	2	2
Overall Study Other	0	3

Baseline Characteristics

Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RotaTeq and Oral Poliovirus (OPV) Concomitantly n=372 Participants Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart	RotaTeq and Oral Poliovirus (OPV) Staggered n=363 Participants Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later	Total n=735 Participants Total of all reporting groups
Age, Customized 5 Weeks of Age and Under	8 participants n=93 Participants	1 participants n=4 Participants	9 participants n=27 Participants
Age, Customized 6 to 12 Weeks of Age	364 participants n=93 Participants	362 participants n=4 Participants	726 participants n=27 Participants
Age, Customized Over 12 Weeks of Age	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Sex: Female, Male Female	189 Participants n=93 Participants	194 Participants n=4 Participants	383 Participants n=27 Participants
Sex: Female, Male Male	183 Participants n=93 Participants	169 Participants n=4 Participants	352 Participants n=27 Participants
Race/Ethnicity, Customized Asian	2 participants n=93 Participants	1 participants n=4 Participants	3 participants n=27 Participants
Race/Ethnicity, Customized Black	10 participants n=93 Participants	7 participants n=4 Participants	17 participants n=27 Participants
Race/Ethnicity, Customized Hispanic American	263 participants n=93 Participants	257 participants n=4 Participants	520 participants n=27 Participants
Race/Ethnicity, Customized Multi-Racial	56 participants n=93 Participants	61 participants n=4 Participants	117 participants n=27 Participants
Race/Ethnicity, Customized White	41 participants n=93 Participants	37 participants n=4 Participants	78 participants n=27 Participants

PRIMARY outcome

Timeframe: Approximately 42 days Postdose 3

Population: The primary immunogenicity analyses were based on evaluable per-protocol subjects who received all scheduled doses, were not protocol violators, and had valid assay values.

GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.

Outcome measures

Outcome measures
Measure	RotaTeq and Oral Poliovirus (OPV) Concomitantly n=355 Participants Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart	RotaTeq and Oral Poliovirus (OPV) Staggered n=318 Participants Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 Antibody Responses to Poliovirus Type 1	888.0 Geometric Mean Titer (GMT) Interval 752.8 to 1047.0	1139 Geometric Mean Titer (GMT) Interval 969.1 to 1340.0
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 Antibody Responses to Poliovirus Type 2	814.9 Geometric Mean Titer (GMT) Interval 720.7 to 921.4	814.5 Geometric Mean Titer (GMT) Interval 707.4 to 937.9
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 Antibody Responses to Poliovirus Type 3	233.6 Geometric Mean Titer (GMT) Interval 201.9 to 270.2	269.2 Geometric Mean Titer (GMT) Interval 230.6 to 314.2

PRIMARY outcome

Timeframe: Approximately 42 days Postdose 3

Population: Per Protocol Population

GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered

Outcome measures

Outcome measures
Measure	RotaTeq and Oral Poliovirus (OPV) Concomitantly n=351 Participants Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart	RotaTeq and Oral Poliovirus (OPV) Staggered n=320 Participants Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)	154.9 GMT Interval 126.4 to 189.9	292.7 GMT Interval 248.6 to 344.6

PRIMARY outcome

Timeframe: Approximately 42 days Postdose 3

Population: Per Protocol Population For serotype G4 the RotaTeq and Oral Poliovirus (OPV) concomitantly group N = 350

Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.

Outcome measures

Outcome measures
Measure	RotaTeq and Oral Poliovirus (OPV) Concomitantly n=352 Participants Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart	RotaTeq and Oral Poliovirus (OPV) Staggered n=321 Participants Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered SNA responses to rotavirus serotypes G1	125.8 GMT Interval 106.7 to 148.2	182.6 GMT Interval 158.2 to 210.7
Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered SNA responses to rotavirus serotypes G2	27.1 GMT Interval 22.9 to 32.0	30.0 GMT Interval 25.9 to 34.8
Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered SNA responses to rotavirus serotypes G3	21.2 GMT Interval 18.4 to 24.32	22.5 GMT Interval 19.4 to 26.0
Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered SNA responses to rotavirus serotypes G4	58.5 GMT Interval 50.2 to 68.1	74.5 GMT Interval 64.3 to 86.3
Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered SNA responses to rotavirus serotypes P1A	84.7 GMT Interval 71.97 to 99.8	131.4 GMT Interval 112.6 to 153.2

Adverse Events

RotaTeq and Oral Poliovirus (OPV) Concomitantly

Serious events: 4 serious events

Other events: 342 other events

Deaths: 0 deaths

RotaTeq and Oral Poliovirus (OPV) Staggered

Serious events: 9 serious events

Other events: 325 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RotaTeq and Oral Poliovirus (OPV) Concomitantly n=366 participants at risk Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart	RotaTeq and Oral Poliovirus (OPV) Staggered n=359 participants at risk Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
Gastrointestinal disorders Intussusception	0.00% 0/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.28% 1/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
General disorders Pyrexia	0.00% 0/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.28% 1/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
Infections and infestations Bronchiolitis	0.55% 2/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.00% 0/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
Infections and infestations Meningitis pneumococcal	0.27% 1/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.00% 0/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
Infections and infestations Pertussis	0.00% 0/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.28% 1/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
Infections and infestations Pneumonia	0.00% 0/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.56% 2/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
Injury, poisoning and procedural complications Head injury	0.27% 1/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.00% 0/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
Injury, poisoning and procedural complications Overdose	0.00% 0/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	1.1% 4/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/366 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.	0.28% 1/359 • Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination. The number of subjects listed in the Adverse Event tables is the number of subjects who received study treatment. Although a subject may have had two or more clinical adverse experiences the patient is counted only once in a category. The same subject may appear in different categories.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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