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CompletedNCT00496054Updated Apr 13, 2017Results posted

Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

A Phase 3 interventional study of Rotavirus Vaccine, Live, Oral, Pentavalent in Gastroenteritis and Rotavirus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-13.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
6 Weeks to 12 Weeks
Sex
All
01

Study summary

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.

02

Conditions studied

  • Gastroenteritis
  • Rotavirus

Browse trials for

03

In context

Gastroenteritis

243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.

This study's enrollment of 110 is below the median of 126 across 160 interventional studies indexed under Gastroenteritis.

Browse Gastroenteritis studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 6 weeks through exactly 12 weeks
  • Healthy infants

Exclusion criteria

Exclusion Criteria:

  • Clinical evidence of active gastrointestinal illness
  • Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
  • History of congenital abdominal disorders, intussusception, or abdominal surgery
  • History of known prior rotavirus disease
  • Known or suspected impairment of immunological function
  • Prior administration of any rotavirus vaccine
  • Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    RotaTeq™ Vaccine (V260)

    Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.

    Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

Interventions

  • BiologicalRotavirus Vaccine, Live, Oral, Pentavalent

    Pentavalent vaccine 9G1, G2, G3, G4 \& P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.

    Also known as: RotaTeq™ Vaccine, V260

06

What researchers measure

Primary outcomes

  1. The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA

    Time frame: Baseline and Approximately 6 Months

  2. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)

    Time frame: Baseline and Approximately 6 Months

  3. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  4. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  5. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  6. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  7. The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)

    Time frame: Baseline and Approximately 6 Months

  8. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA

    Time frame: Baseline and Approximately 6 Months

  9. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1

    Time frame: Baseline and Approximately 6 Months

  10. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2

    Time frame: Baseline and Approximately 6 Months

  11. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3

    Time frame: Baseline and Approximately 6 Months

  12. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4

    Time frame: Baseline and Approximately 6 Months

  13. The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1

    Time frame: Baseline and Approximately 6 Months

07

Results

Posted Mar 11, 2010

Participant flow

Phase III First Patient In (FPI): 09-May-2008 Last Patient Out (LPO): 20-Nov-2008 Multi-center study 1. Department of Paediatrics, Kashyap Nursing Home, Mumbai. 2. Department of Paediatrics, KEM Hospital, Pune 3. Department of Paediatrics, J.K.Lon, SMS Hospital, Jaipur 4. Panchsheel Hospital, Delhi

Participant flow — Overall Study
MilestoneRotaTeq™ Vaccine (V260)
Started110
Completed102
Not completed8
Withdrew: Adverse event1
Withdrew: Lost to follow-up7

Outcome measures

PrimaryThe Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA82.35 (74.95 to 89.75)
PrimaryThe Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA82.83 (75.40 to 90.26)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)38.24 (28.81 to 47.67)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)14.71 (7.84 to 21.58)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)30.39 (21.46 to 39.32)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)37.25 (27.87 to 46.63)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)30.39 (21.46 to 39.32)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)37.37 (27.84 to 46.90)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)14.14 (7.28 to 21.00)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)29.29 (20.33 to 38.25)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)35.35 (25.93 to 44.77)
PrimaryThe Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Time frame:
Baseline and Approximately 6 Months
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Percentage of ParticipantsRotaTeq™ Vaccine (V260)
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)29.29 (20.33 to 38.25)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
TiterRotaTeq™ Vaccine (V260)
IgA GMT at Baseline3.81 (2.74 to 5.29)
IgA GMT at 6 Months79.95 (55.23 to 115.73)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
TiterRotaTeq™ Vaccine (V260)
IgA GMT at Baseline3.68 (2.66 to 5.09)
IgA GMT at 6 Months75.12 (51.67 to 109.22)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
TiterRotaTeq™ Vaccine (V260)
G1 GMT at Baseline43.53 (35.59 to 53.24)
G1 GMT at 6 Months85.79 (68.65 to 107.20)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
TiterRotaTeq™ Vaccine (V260)
G2 GMT at Baseline63.25 (53.46 to 74.83)
G2 GMT at 6 Months50.33 (41.66 to 60.81)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
TiterRotaTeq™ Vaccine (V260)
G3 GMT at Baseline27.22 (21.23 to 34.90)
G3 GMT at 6 Months34.32 (26.71 to 44.09)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
TiterRotaTeq™ Vaccine (V260)
G4 GMT at Baseline51.91 (43.29 to 62.23)
G4 GMT at 6 Months84.43 (69.36 to 102.79)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
TiterRotaTeq™ Vaccine (V260)
P1 GMT at Baseline86.61 (69.48 to 107.95)
P1 GMT at 6 Months104.56 (82.86 to 131.94)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
TiterRotaTeq™ Vaccine (V260)
G1 GMT at Baseline43.11 (35.07 to 52.98)
G1 GMT at 6 Months81.19 (65.15 to 101.19)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
TiterRotaTeq™ Vaccine (V260)
G2 GMT at Baseline62.91 (52.91 to 74.79)
G2 GMT at 6 Months49.21 (40.62 to 59.61)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
TiterRotaTeq™ Vaccine (V260)
G3 GMT at Baseline27.71 (21.48 to 35.73)
G3 GMT at 6 Months32.95 (25.60 to 42.42)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
TiterRotaTeq™ Vaccine (V260)
G4 GMT at Baseline51.74 (42.94 to 62.35)
G4 GMT at 6 Months80.88 (65.52 to 98.34)
PrimaryThe Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
Time frame:
Baseline and Approximately 6 Months
Reported as:
Geometric mean · Titer
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
TiterRotaTeq™ Vaccine (V260)
P1 GMT at Baseline84.17 (67.27 to 105.31)
P1 GMT at 6 Months100.01 (79.28 to 126.15)

Adverse events

Collected over 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RotaTeq™ Vaccine (V260)—1/104 (1%)47/104 (45.2%)
Most frequent serious events
Most frequent serious events
EventRotaTeq™ Vaccine (V260)
MeningitisInfections and infestations1/104
Most frequent other events
Most frequent other events
EventRotaTeq™ Vaccine (V260)
DiarrhoeaGastrointestinal disorders22/104
VomitingGastrointestinal disorders19/104
PyrexiaGeneral disorders14/104
NasopharyngitisInfections and infestations8/104
CoughRespiratory, thoracic and mediastinal disorders4/104
Abdominal painGastrointestinal disorders2/104
Ear PainEar and labyrinth disorders1/104
IrritabilityGeneral disorders1/104
MeningitisInfections and infestations1/104

Baseline characteristics

Age, Continuous
Age, Continuous(Days)RotaTeq™ Vaccine (V260)
Mean59.01 ± 13.52
Sex: Female, Male
Sex: Female, Male(Participants)RotaTeq™ Vaccine (V260)
Female47
Male63
Height
Height(Centimeters)RotaTeq™ Vaccine (V260)
Mean57.61 ± 5.04
Temperature
Temperature(Fahrenheit)RotaTeq™ Vaccine (V260)
Mean98.58 ± 0.70
Weight
Weight(Kilograms)RotaTeq™ Vaccine (V260)
Mean4.73 ± 0.71
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Lokeshwar MR, Bhave S, Gupta A, Goyal VK, Walia A. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Hum Vaccin Immunother. 2013 Jan;9(1):172-6. doi: 10.4161/hv.22341. PubMed 23442588 ↗

Individual participant data

Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00496054
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 4, 2007
Start date
May 2008
Primary completion
Oct 2008
Completion
Oct 2008
Results posted
Mar 11, 2010
Last update
Apr 13, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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