Trial Outcomes & Findings for Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh (NCT NCT01375647)
NCT ID: NCT01375647
Last Updated: 2025-04-29
Results Overview
Any Sabin type poliovirus in any fecal samples at days 0, 4, 11, 18 or 25 following week 52 dose
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
700 participants
Primary outcome timeframe
25 days following week 52 visit
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
Rotarix + IPV (Inactivated Polio Vaccine)
Rotarix vaccine at 10 and 17 weeks of age plus IPV (inactivated polio vaccine) boost at 39 weeks in place of routine oral polio vaccine dose
|
Rotarix + No IPV (Inactivated Polio Vaccine)
Rotarix vaccine at 10 and 17 weeks of age and routine oral polio vaccine series
|
No Rotarix + IPV (Inactivated Polio Vaccine)
IPV (inactivated polio vaccine) boost at 39 weeks in place of routine oral polio vaccine dose
|
No Rotarix + No IPV (Inactivated Polio Vaccine)
No Rotarix vaccine and routine oral polio vaccine series
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
175
|
175
|
|
Overall Study
COMPLETED
|
153
|
150
|
141
|
151
|
|
Overall Study
NOT COMPLETED
|
22
|
25
|
34
|
24
|
Reasons for withdrawal
| Measure |
Rotarix + IPV (Inactivated Polio Vaccine)
Rotarix vaccine at 10 and 17 weeks of age plus IPV (inactivated polio vaccine) boost at 39 weeks in place of routine oral polio vaccine dose
|
Rotarix + No IPV (Inactivated Polio Vaccine)
Rotarix vaccine at 10 and 17 weeks of age and routine oral polio vaccine series
|
No Rotarix + IPV (Inactivated Polio Vaccine)
IPV (inactivated polio vaccine) boost at 39 weeks in place of routine oral polio vaccine dose
|
No Rotarix + No IPV (Inactivated Polio Vaccine)
No Rotarix vaccine and routine oral polio vaccine series
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
7
|
10
|
|
Overall Study
Death
|
1
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
17
|
20
|
26
|
14
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Baseline characteristics by cohort
| Measure |
Rotarix + IPV (Inactivated Polio Vaccine)
n=175 Participants
Rotarix vaccine at 10 and 17 weeks of age plus IPV (inactivated polio vaccine) boost in place of the routine oral polio vaccine dose at 39 weeks
|
Rotarix + No IPV (Inactivated Polio Vaccine)
n=175 Participants
Oral Rotarix vaccine at 10 and 17 weeks of age and regular routine oral polio vaccine series
|
No Rotarix + IPV (Inactivated Polio Vaccine)
n=175 Participants
No Rotarix vaccine and IPV (inactivated polio vaccine) boost in place of the routine oral polio vaccine dose at 39 weeks
|
No Rotarix + No IPV (Inactivated Polio Vaccine)
n=175 Participants
No Rotarix vaccine and routine oral polio vaccine series
|
Total
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
5 days
n=5 Participants
|
5 days
n=7 Participants
|
6 days
n=5 Participants
|
5 days
n=4 Participants
|
5 days
n=21 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
332 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
368 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
175 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
700 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
175 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
700 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Bangladesh
|
175 participants
n=5 Participants
|
175 participants
n=7 Participants
|
175 participants
n=5 Participants
|
175 participants
n=4 Participants
|
700 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 25 days following week 52 visitPopulation: Intention to treat. All participants analyzed as randomized
Any Sabin type poliovirus in any fecal samples at days 0, 4, 11, 18 or 25 following week 52 dose
Outcome measures
| Measure |
IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive IPV (inactivated polio vaccine) boost, regardless of whether they received Rotarix
|
No IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive oral polio series only and no IPV (inactivated polio vaccine) boost dose, regardless of whether they received Rotarix
|
|---|---|---|
|
Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial)
|
99 Participants
|
109 Participants
|
PRIMARY outcome
Timeframe: Birth to one yearPopulation: Intention to treat. All randomized participants are analyzed in the arms to which they were randomized.
Diarrheal episode defined as presence of 3 or more abnormally loose stools in 24h period with \>=72 hours separating episodes. Rotavirus antigen detected by ELISA in diarrheal stool.
Outcome measures
| Measure |
IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive IPV (inactivated polio vaccine) boost, regardless of whether they received Rotarix
|
No IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive oral polio series only and no IPV (inactivated polio vaccine) boost dose, regardless of whether they received Rotarix
|
|---|---|---|
|
Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial)
|
67 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: from day 4 to day 25 following the week 52 visitPopulation: This differs from the total population because it is a subset of total participants, limited to only those who shed the virus as determined by quantitative PCR assay (qPCR) Number analyzed differs from the number of participants shedding in outcome 5 (Presence of fecal polio virus shedding) because this shedding subset is determined using a different assay and time frame
Shedding index, calculated as duration days multiplied by mean log (shedding amount) for Sabin types 1, 2, and 3. Outcome is conditioned on infants with at least one detection by quantitative PCR (qPCR) at day 4,11,18, or 25. If shedding data point was missing it was assumed that the infant was not shedding at that time. Lower shedding index is better outcome
Outcome measures
| Measure |
IPV (Inactivated Polio Vaccine)
n=90 Participants
All who were randomized to receive IPV (inactivated polio vaccine) boost, regardless of whether they received Rotarix
|
No IPV (Inactivated Polio Vaccine)
n=81 Participants
All who were randomized to receive oral polio series only and no IPV (inactivated polio vaccine) boost dose, regardless of whether they received Rotarix
|
|---|---|---|
|
Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial)
Sabin type 1
|
17.9 units on a scale
Standard Deviation 4.8
|
18.5 units on a scale
Standard Deviation 4.5
|
|
Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial)
Sabin type 2
|
18.4 units on a scale
Standard Deviation 4.7
|
19.6 units on a scale
Standard Deviation 3.8
|
|
Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial)
Sabin type 3
|
17.7 units on a scale
Standard Deviation 4.5
|
16.4 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: post 52 weeksOnly 8 infants were shedding at baseline so results are not presented for this outcome due to insufficient data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 25 days following week 52 visitPopulation: Total Intention to treat population, all participants are included as randomized Number shedding differs from the number analyzed in outcome 3 (Duration of fecal shedding of polio vaccine virus) because shedding detection here is based on positive/negative PCR assay result
Frequency (%) of infants excreting poliovirus at any of the 5 time points (day 0, 4,11,18, 25) post week 52 oral polio vaccine dose. Presence of poliovirus is determined by polymerase chain reaction (PCR)
Outcome measures
| Measure |
IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive IPV (inactivated polio vaccine) boost, regardless of whether they received Rotarix
|
No IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive oral polio series only and no IPV (inactivated polio vaccine) boost dose, regardless of whether they received Rotarix
|
|---|---|---|
|
Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial)
Sabin type 1
|
67 Participants
|
72 Participants
|
|
Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial)
Sabin type 2
|
22 Participants
|
33 Participants
|
|
Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial)
Sabin type 3
|
40 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 18-40 weeksPopulation: Intention to treat
Seropositive defined as antibodies present at ≥1:8 dilution, antibody titers \<1:8 were seronegative. Non-seroconversions are those who did not seroconvert between week 18 (post oral polio vaccine dose 2) and week 40, adjusted for residual maternal antibody
Outcome measures
| Measure |
IPV (Inactivated Polio Vaccine)
n=233 Participants
All who were randomized to receive IPV (inactivated polio vaccine) boost, regardless of whether they received Rotarix
|
No IPV (Inactivated Polio Vaccine)
n=215 Participants
All who were randomized to receive oral polio series only and no IPV (inactivated polio vaccine) boost dose, regardless of whether they received Rotarix
|
|---|---|---|
|
Serum Neutralizing Antibody Response (Polio Trial)
Non-seroconversion Sabin type 1
|
9 Participants
|
79 Participants
|
|
Serum Neutralizing Antibody Response (Polio Trial)
Non-seroconversion Sabin type 2
|
9 Participants
|
62 Participants
|
|
Serum Neutralizing Antibody Response (Polio Trial)
Non-seroconversion Sabin type 3
|
13 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: Birth to one yearPopulation: Intention to treat population, included as randomized
A diarrheal episode is defined as the presence of 3 or more abnormally loose stools in a 24 hour period with at least 72 diarrhea-free hours separating distinct episodes
Outcome measures
| Measure |
IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive IPV (inactivated polio vaccine) boost, regardless of whether they received Rotarix
|
No IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive oral polio series only and no IPV (inactivated polio vaccine) boost dose, regardless of whether they received Rotarix
|
|---|---|---|
|
Total Number of Diarrheal Episodes (Rotavirus Trial)
|
3 episodes
Interval 1.0 to 5.0
|
3 episodes
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Birth to one yearPopulation: Intention to treat, all included as randomized
A diarrheal episode is defined as the presence of 3 or more abnormally loose stools in a 24 hour period with at least 72 diarrhea-free hours separating distinct episodes. Rotavirus positive specimens were determined by ELISA Those with no rotavirus diarrheal episodes are counted as duration 0
Outcome measures
| Measure |
IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive IPV (inactivated polio vaccine) boost, regardless of whether they received Rotarix
|
No IPV (Inactivated Polio Vaccine)
n=350 Participants
All who were randomized to receive oral polio series only and no IPV (inactivated polio vaccine) boost dose, regardless of whether they received Rotarix
|
|---|---|---|
|
Total Duration of Rotavirus-associated Diarrheal Episodes (Rotavirus Trial)
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 4.0
|
Adverse Events
Rotarix + IPV
Serious events: 16 serious events
Other events: 0 other events
Deaths: 2 deaths
Rotarix + No IPV
Serious events: 16 serious events
Other events: 0 other events
Deaths: 2 deaths
No Rotarix + IPV
Serious events: 20 serious events
Other events: 0 other events
Deaths: 1 deaths
No Rotarix + No IPV
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotarix + IPV
n=175 participants at risk
Rotarix vaccine at 10 and 17 weeks of age plus inactivated polio vaccine in place of the routine oral polio vaccine dose at 39 weeks
|
Rotarix + No IPV
n=175 participants at risk
Rotarix vaccine at 10 and 17 weeks of age and routine oral polio vaccine series
|
No Rotarix + IPV
n=175 participants at risk
No Rotarix vaccine and inactivated polio vaccine in place of the routine oral polio vaccine dose at 39 weeks
|
No Rotarix + No IPV
n=175 participants at risk
No Rotarix vaccine and routine oral polio vaccine series
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.6%
8/175 • Number of events 9 • Birth to one year
|
8.0%
14/175 • Number of events 15 • Birth to one year
|
9.7%
17/175 • Number of events 17 • Birth to one year
|
9.7%
17/175 • Number of events 19 • Birth to one year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory illness
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
1.7%
3/175 • Number of events 4 • Birth to one year
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.1%
2/175 • Number of events 2 • Birth to one year
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
|
Cardiac disorders
Cyanosis
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
|
Infections and infestations
Sepsis
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
|
General disorders
Febrile Illness
|
1.1%
2/175 • Number of events 2 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
|
Gastrointestinal disorders
Inguinal heria
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
|
Nervous system disorders
Convulsions
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.57%
1/175 • Number of events 2 • Birth to one year
|
|
Gastrointestinal disorders
Vomiting
|
0.57%
1/175 • Number of events 1 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
0.00%
0/175 • Birth to one year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place