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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00130832

First received: August 12, 2005

Last updated: January 27, 2011

Last verified: January 2011

History of Changes

Results First Received: August 7, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Rotavirus Infections Gastroenteritis
Interventions:	Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Comparator: Oral Poliovirus Vaccine (OPV) Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	RotaTeq and Oral Poliovirus (OPV) Concomitantly	RotaTeq and Oral Poliovirus (OPV) Staggered
STARTED	372	363
COMPLETED	356 ^[1]	346 ^[2]
NOT COMPLETED	16	17
Adverse Event	1	1
Lost to Follow-up	1	2
Protocol Violation	6	8
Withdrawal by Subject	6	1
Moved	2	2
Unspecified	0	3

[1]	Those who received all 3 doses of concomitant RotaTeq™/ OPV with blood draw ~42 days postdose 3
[2]	Those who received all 3 doses; last 2 blood draws ~42 days postdose 3 of RotaTeq™ and postdose OPV

Baseline Characteristics

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Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	RotaTeq and Oral Poliovirus (OPV) Concomitantly	RotaTeq and Oral Poliovirus (OPV) Staggered	Total
Number of Participants [units: participants]	372	363	735
Age, Customized [units: participants]
5 Weeks of Age and Under	8	1	9
6 to 12 Weeks of Age	364	362	726
Over 12 Weeks of Age	0	0	0
Gender [units: participants]
Female	189	194	383
Male	183	169	352
Race/Ethnicity, Customized [units: participants]
Asian	2	1	3
Black	10	7	17
Hispanic American	263	257	520
Multi-Racial	56	61	117
White	41	37	78

Outcome Measures

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1. Primary:

Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 [ Time Frame: Approximately 42 days Postdose 3 ]

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2. Primary:

GMT of Serum Anti-rotavirus Immunoglobulin A (IgA) [ Time Frame: Approximately 42 days Postdose 3 ]

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3. Primary:

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 [ Time Frame: Approximately 42 days Postdose 3 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination.
Additional Description	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.

Time Frame

Subjects in this study were followed for all adverse experiences, for 14 days following each study vaccination.

Additional Description

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.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
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

Other Adverse Events

	RotaTeq and Oral Poliovirus (OPV) Concomitantly	RotaTeq and Oral Poliovirus (OPV) Staggered
Total, other (not including serious) adverse events
# participants affected / at risk	342/366	325/359
Eye disorders
Conjunctivitis ^{* 1}
# participants affected / at risk	8/366 (2.19%)	7/359 (1.95%)
Gastrointestinal disorders
Abdominal pain ^{* 1}
# participants affected / at risk	2/366 (0.55%)	4/359 (1.11%)
Constipation ^{* 1}
# participants affected / at risk	13/366 (3.55%)	18/359 (5.01%)
Diarrhoea ^{* 1}
# participants affected / at risk	195/366 (53.28%)	185/359 (51.53%)
Flatulence ^{* 1}
# participants affected / at risk	7/366 (1.91%)	4/359 (1.11%)
Gastrooesophageal reflux disease ^{* 1}
# participants affected / at risk	5/366 (1.37%)	5/359 (1.39%)
Infantile colic ^{* 1}
# participants affected / at risk	34/366 (9.29%)	37/359 (10.31%)
Vomiting ^{* 1}
# participants affected / at risk	123/366 (33.61%)	121/359 (33.70%)
General disorders
Influenza like illness ^{* 1}
# participants affected / at risk	7/366 (1.91%)	8/359 (2.23%)
Injection site pain ^{* 1}
# participants affected / at risk	16/366 (4.37%)	21/359 (5.85%)
Irritability ^{* 1}
# participants affected / at risk	24/366 (6.56%)	33/359 (9.19%)
Pain ^{* 1}
# participants affected / at risk	3/366 (0.82%)	6/359 (1.67%)
Pyrexia ^{* 1}
# participants affected / at risk	203/366 (55.46%)	202/359 (56.27%)
Infections and infestations
Bronchiolitis ^{* 1}
# participants affected / at risk	10/366 (2.73%)	9/359 (2.51%)
Bronchitis ^{* 1}
# participants affected / at risk	5/366 (1.37%)	4/359 (1.11%)
Ear infection ^{* 1}
# participants affected / at risk	6/366 (1.64%)	5/359 (1.39%)
Influenza ^{* 1}
# participants affected / at risk	28/366 (7.65%)	38/359 (10.58%)
Nasopharyngitis ^{* 1}
# participants affected / at risk	85/366 (23.22%)	86/359 (23.96%)
Oral candidiasis ^{* 1}
# participants affected / at risk	7/366 (1.91%)	4/359 (1.11%)
Otitis media ^{* 1}
# participants affected / at risk	2/366 (0.55%)	5/359 (1.39%)
Pharyngitis ^{* 1}
# participants affected / at risk	32/366 (8.74%)	37/359 (10.31%)
Rhinitis ^{* 1}
# participants affected / at risk	14/366 (3.83%)	17/359 (4.74%)
Musculoskeletal and connective tissue disorders
Muscle spasms ^{* 1}
# participants affected / at risk	4/366 (1.09%)	3/359 (0.84%)
Pain in extremity ^{* 1}
# participants affected / at risk	23/366 (6.28%)	18/359 (5.01%)
Nervous system disorders
Headache ^{* 1}
# participants affected / at risk	2/366 (0.55%)	4/359 (1.11%)
Psychiatric disorders
Crying ^{* 1}
# participants affected / at risk	3/366 (0.82%)	5/359 (1.39%)
Restlessness ^{* 1}
# participants affected / at risk	8/366 (2.19%)	16/359 (4.46%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm ^{* 1}
# participants affected / at risk	2/366 (0.55%)	5/359 (1.39%)
Cough ^{* 1}
# participants affected / at risk	54/366 (14.75%)	52/359 (14.48%)
Dyspnoea ^{* 1}
# participants affected / at risk	2/366 (0.55%)	5/359 (1.39%)
Nasal congestion ^{* 1}
# participants affected / at risk	16/366 (4.37%)	19/359 (5.29%)
Respiratory distress ^{* 1}
# participants affected / at risk	2/366 (0.55%)	5/359 (1.39%)
Skin and subcutaneous tissue disorders
Dermatitis ^{* 1}
# participants affected / at risk	9/366 (2.46%)	13/359 (3.62%)
Dermatitis atopic ^{* 1}
# participants affected / at risk	8/366 (2.19%)	5/359 (1.39%)
Dermatitis diaper ^{* 1}
# participants affected / at risk	11/366 (3.01%)	9/359 (2.51%)
Rash ^{* 1}
# participants affected / at risk	5/366 (1.37%)	7/359 (1.95%)
Seborrhoeic dermatitis ^{* 1}
# participants affected / at risk	4/366 (1.09%)	2/359 (0.56%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (9.0)

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00130832 History of Changes
Other Study ID Numbers:	V260-014, 2005_030
Study First Received:	August 12, 2005
Results First Received:	August 7, 2009
Last Updated:	January 27, 2011
Health Authority:	Brazil: Ministry of Health

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