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Table 3 Age and seropositivity rates at pre-dose-1 and post-last-dose time points in the placebo groups (of the Total vaccinated cohort)

From: Early exposure of infants to natural rotavirus infection: a review of studies with human rotavirus vaccine RIX4414

Region

Countries

Study number

Mean age at pre-dose-1 (weeks) ± SD

Seropositivity rate at pre-dose-1

Mean age at last-dose of placebo (weeks) ± SD

Time between last-dose of placebo and post-last-dose blood draw (weeks)

Seropositivity rate post-last-dose

% (n/N)

% (n/N)

Africa

South Africa

444563/013 (Rota-013)

6.4 ± 1.07

4.3 (4/94)

15.0 ± 2.32

8

6.3 (5/80)

South Africa

444563/022 (Rota-022)

6.9 ± 1.02

13.0 (6/46)

14.9 ± 1.64

8

29.4 (10/34)

South Africa, Malawi

102248 (Rota-037)

6.4 ± 0.97

11.5 (18/157)

16.3 ± 1.51

4

25.2 (348/1380)

Asia

Korea

103478 (Rota-041)

10.5 ± 0.92

23.1 (12/52)

19.4 ± 1.09

8

20.4 (10/49)

India

103792 (Rota-044)

8.6 ± 0.69

26.3 (45/171)

13.5 ± 1.12

4

26.2 (43/164)

Bangladesh

103992 (Rota-045)

12.2 ± 0.47

15.2 (14/92)

16.8 ± 0.52

4

34.8 (32/92)

Singapore, Hong Kong, Taiwan

444563 (Rota-028, −029, −030)

11.6 ± 2.37

0.7 (1/135)

17.8 ± 1.55

4–8

1.5 (2/132)

Latin America

Brazil, Mexico and Venezuela

444563/006 (Rota 006)

8.6 ± 1.98

2.1 (11/528)

NA*

8

13.2 (24/182)

Argentina, Brazil, Chile, Colombia, Dominican Republic, Honduras, Mexico, Nicaragua, Panama, Peru and Venezuela

444563/023 (Rota 023)

8.4 ± 2.37

3.5 (15/432)

16.3 ± 3.77

4–8

15.1 (60/398)

Mexico, Colombia, Peru

444563/033 (Rota-033)

8.6 ± 2.20

3.3 (4/121)

NA*

8

13.1 (14/107)

Dominican Republic

106260 (Rota-052)

8.2 ± 1.80

9.3 (9/97)

14.2 ± 1.83

6

30.2 (29/96)

Europe

Finland

444563/003 (Rota 003)

7.6 ± 1.75

0.0 (0/16)

NA*

4

0.0 (0/14)

Finland

104480 (Rota-048)

9.3 ± 2.04

0.0 (0/49)

14.4 ± 2.12

4

0.0 (0/48)

Finland, Czech Republic, France, Germany, Italy, Spain

102247 (Rota-036)

11.4 ± 1.84

2.1 (10/479)

19.6 ± 2.74

12

9.5 (45/473)

France, Portugal, Poland and Spain

106481 (Rota-054)

8.5 ± 1.78

9.4 (9/96)

16.0 ± 2.95

4

21.3 (20/94)

North America

United States and Canada

444563/005 (Rota 005)

8.6 ± 1.31

0.0 (0/95)

NA*

8

9.3 (8/86)

  1. SD = Standard deviation.
  2. n = number of infants in placebo groups with anti-rotavirus IgA antibody concentration ≥20 U/ml.
  3. N = number of infants in placebo groups with available results.
  4. Note: In all the studies mentioned above, the assessment of seropositivity rates was performed on a subset of total number of enrolled infants.
  5. NA* = No age data calculated for the post-last-dose time point.