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Table 2 Description of study population according to randomization groups

From: Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea

 

10vPCV

13vPCV

Number enrolled

131

131

Male, number (%) at enrolment

66 (50%)

72 (55%)

Age (days) at study visits

Visit 1 m/PCV1, mean ± sd

30.9 ± 2.5 (n = 131)

31.0 ± 2.2 (n = 131)

 (Min-Max)

(25–39)

(27–40)

Visit 2 m/PCV2, mean ± sd

61.6 ± 3.4 (n = 122)

61.9 ± 4.0 (n = 121)

 (Min-Max)

(55–77)

(56–84)

Visit 3 m/PCV3, mean ± sd

94.0 ± 7.8 (n = 119)

92.5 ± 4.4 (n = 109)

 (Min-Max)

(84–134)

(84–112)

Weight (kg)

Birth weight, mean ± sd

3.4 ± (n = 97)

3.3 ± (n = 105)

 (Min-Max)

(2.2–4.5)

(2.3–4.5)

Visit 1 m, mean ± sd

4.4 ± 0.7 (n = 127)

4.3 ± 0.5 (n = 126)

 (Min-Max)

(2.5–6.1)

(2.7–5.7)

Visit 2 m, mean ± sd

5.3 ± 0.7 (n = 122)

5.3 ± 0.7 (n = 120)

 (Min-Max)

(3.4–6.8)

(2.9–7.2)

Visit 3 m, mean ± sd

6.1 ± 0.9 (n = 114)

6.0 ± 0.8 (n = 108)

 (Min-Max)

(4.0–8.5)

(4.1–8.1)

 

10vPCV

13vPCV

No PPV

PPV

No PPV

PPV

Number followed-up at 9 months

57

51

48

52

Male, number (%) at 9 months

29 (51%)

24 (43%)

26 (54%)

29 (54%)

Age (months)

Visit 9 m, mean ± sd

9.2 ± 0.7 (n = 57)

9.5 ± 1.2 (n = 51)

9.06 ± 0.2 (n = 48)

9.2 ± 0.5 (n = 52)

 (Min-Max)

(8.2–13.1)

(8.9–14.4)

(8.6–9.9)

(8.9–11.9)

Visit 23 m, mean ± sd

23.4 ± 0.8 (n = 47)

23.3 ± 0.6 (n = 46)

23.3 ± 0.8 (n = 40)

23.3 ± 0.7 (n = 46)

 (Min-Max)

(22.1–27.1)

(22.9–26.3)

(22.9–26.5)

(22.6–26.0)

Visit 24 m, mean ± sd

24.5 ± 1.0 (n = 47)

24.6 ± 0.9 (n = 44)

24.4 ± 0.8 (n = 40)

24.5 ± 1.1 (n = 45)

 (Min-Max)

(23.2–28.1)

(23.9–27.9)

(23.9–30.1)

(23.7–30.1)

Weight (kg)

Visit 9 m, mean ± sd

8.4 ± 1.1 (n = 53)

8.1 ± 1.3 (n = 51)

8.1 ± 0.8 (n = 45)

8.0 ± 0.9 (n = 52)

 (Min-Max)

(6.5–11.2)

(6.3–14.0)

(6.5–10.4)

(6.6–10.5)

Visit 23 m, mean ± sd

11.3 ± 1.2 (n = 44)

10.7 ± 1.4 (n = 42)

10.9 ± 1.3 (n = 38)

11.0 ± 1.5 (n = 37)

 (Min-Max)

(9.7–14.0)

(7.7–14.0)

(8.8–14.0)

(8.9–15.0)

Visit 24 m, mean ± sd

11.7 ± 1.5 (n = 44)

11.3 ± 1.4 (n = 40)

11.3 ± 1.2 (n = 35)

11.17 ± 1.4 (n = 42)

 (Min-Max)

(8.9–15.0)

(8.1–14.0)

(9.0–14.0)

(9.0–15.0)