Background
Date commenced | Vaccine | Age (mo) |
---|---|---|
1st July 2001 | PCV7 & PPV23 | 2,4,6 18 |
1st October 2009* | PHiD-CV10 | 2,4,6,18 |
1st October 2011 | PCV13 | 2,4,6,18 |
Methods
Study design, setting, community recruitment and ethical approval
Participant recruitment and consent
Inclusion and exclusion criteria
Clinical assessments
Ear examinations and general health assessments
General health measures
Definitions of OM
Medical record review
Risk factor questionnaires
Statistical analysis
Missing data
Results
Participant exclusions and PCV vaccination status
Doses of PCV7 | Doses of PHiD-CV10 | |||||
---|---|---|---|---|---|---|
0 | 1 | 2 | 3 | 4 | TOTAL | |
0 | 33e
| 18 e
| 50 | 284 | 77 | 411 |
1 | 5 e
| 2 e
| 23 | 16 | 1 | 40 |
2 | 28 | 15 | 30 e
| 43 | ||
3 | 322 | 73 | 1 e
| 395¥
| ||
4 | 5 | 1 | 6 | |||
+ PPV23§
| 138§
| |||||
+ PCV13¥
| 2¥
| 0 | 19¥
| 70¥
| 1¥
| 92¥
|
TOTAL
| 355 | 89 | 73 | 300 | 78 | 895 |
Region and communities
Participant characteristics
Age, gestational age, birth weight and gender
PCV7 | PHiD-CV1 | Absolute difference in mean or % [95% CI] | P* | |||
---|---|---|---|---|---|---|
N | Mean (SD) or% | N | Mean (SD) or% | |||
Age (mo) | 444 | 20 (8) | 451 | 18 (7) | 2 [1-3] | 0.0001 |
0 to <3 | 0 | 0 | ||||
3 to <6 | 8 | 2% | 9 | 2% | ||
6 to <9 | 48 | 11% | 60 | 13% | ||
9 to <12 | 39 | 9% | 46 | 10% | ||
12 to <18 | 87 | 20% | 118 | 26% | ||
18 to <24 | 102 | 23% | 106 | 24% | ||
24 to <36 | 160 | 36% | 112 | 25% | ||
Gestational age (weeks) | 378 | 37.7 (2.8) | 426 | 38.1 (2.3) | 0.4 [0 to 0.7] | 0.04 |
Birth weight (kg) | 431 | 2.97 (0.65) | 431 | 3.06 (0.61) | 0.09 [0.00 to 0.17] | 0.04 |
Sex (female) | 210 | 47% | 230 | 51% | 4% [−3 to 10] | 0.27 |
General health
| ||||||
SKIN assessed | 434/444 | 98% | 435/451 | 96% | ||
Normal | 326 | 75% | 303 | 70% | −5% [−11 to 0] | 0.07 |
Scabies | 19 | 4% | 53 | 12% | 8% [−4 to 11] |
<0.0001
|
Impetigo | 62 | 14% | 67 | 15% | 1% [−4 to 6] | 0.64 |
Tinea | 19 | 2% | 13 | 3% | 1% [−1 to 3] | 0.39 |
other | 20 | 6% | 27 | 6% | 0% [−3 to 3] | 0.96 |
Runny Nose | 165/432 | 38% | 198/445 | 44% | 6% [0 to 13] | 0.06 |
Any cough | 86/436 | 20% | 169/457 | 38% | 18% [12 to 24] |
<0.0001
|
Other
| ||||||
Any antibiotics prescribed in previous 5 weeks | 130/444 | 29% | 189/451 | 42% | 12% [6 to 19] |
0.0001
|
Beta-lactam | 101/444 | 23% | 158 | 35% | 12% [6-18] |
0.0001
|
Macrolide | 14/444 | 3% | 18 | 4% | 1% [−2 to 3] | 0.50 |
Topical | 18/426 | 4% | 18/433 | 4% | 0% [−3 to 3] | 0.97 |
Haemoglobin (<11 mg/dL) | 122/402 | 30% | 139/403 | 34% | 4% [−2 to 11] | 0.21 |
General health
Risk factor questionnaire respondents
PCV7 | PHiD-CV10 | Absolute difference in mean or % [95% CI] | P* | |||
---|---|---|---|---|---|---|
N | Mean (SD) or % | N | Mean (SD) or % | |||
Risk factor questionnaire response | ||||||
No parents consented |
413/444
| 93% |
296/451
| 66% | −27% [−32 to −22] |
<0.0001
|
Mother interviewed | 400/413 | 97% | 290/296 | 98% | 1% [−1 to 3] | 0.36 |
Characteristics of children in consented subgroups
| ||||||
PCV7
|
PHiD-CV10
| |||||
Age (months) | 413 | 20 (8) | 296 | 18(7) | 2.0 [0.9 to 3.2] |
0.0008
|
Sex (female) | 198 | 48% | 151 | 51% | 3% [−4 to 11] | 0.42 |
Any Suppurative OM | 208/395 | 53% | 104/285 | 36% | −16% [−24 to −9] |
<0.0001
|
Risk factors
| ||||||
Crowding (persons per household) | 402 | 8.6 (4.5) | 290 | 8.2 (3.9) | −0.4 [−1.0 to 0.3] | 0.23 |
Crowding (children < 5 years of age per household) | 408 | 2.4 (1.6) | 291 | 2.1 (1.2) | −0.3 [−0.5 to −0.1] |
0.01
|
Crowding Index (%households with > 2 additional children < 5 years of age) | 132/408 | 32% | 75/291 | 26% | −6% [−13 to 0.2] | 0.06 |
Child Care (any attendance > 3 days per week) | 51/409 | 12% | 41/295 | 14% | 1.4% [−4 to 7] | 0.58 |
Child Care (days/week) | 408 | 0.68 (1.7) | 295 | 0.77 (1.7) | 0.09 [−0.34 to 0.16] | 0.49 |
Washed with soap yesterday | 327/362 | 90% | 258/293 | 88% | −2% [−7 to 3] | 0.35 |
Any sibling with history of “runny ears” | 101/370 | 27% | 80/249 | 32% | 5% [−3 to 12] | 0.20 |
Child near campfire last week | 134/402 | 34% | 88/287 | 31% | −3% [−10 to 4] | 0.46 |
Maternal smoking | 233/410 | 57% | 178/283 | 61% | 4% [−3 to 11] | 0.29 |
Maternal age at birth of this child | 297 | 25 (5.4) | 244 | 26 (6.4) | 1 [0.1 to 2] |
0.04
|
Maternal education (certificate) | 105/382 | 27% | 60/247 | 24% | −3% [−10 to 4] | 0.37 |
Never breast fed | 28/409 | 7% | 14/296 | 5% | −2% [−6 to 1] | 0.23 |
Pacifier (ever) | 78/404 | 19% | 52/296 | 18% | −2% [−8 to 4] | 0.56 |
Comparison of risk factor prevalence among PCV7 and PHiD-CV10 subgroups
Primary outcome: otitis media, by vaccine group and age
Otitis media
PCV7 444 | PHiD-CV10 451 | Absolute risk difference [95%CI] | P value | |||
---|---|---|---|---|---|---|
n | % | n | % | |||
No. children without assessment | 12 | 3% | 14 | 3% | ||
No. children with diagnosis based on tympanometry alone | 4 | 1% | 0 | 0% | ||
No. children with unilateral otoscopy | 27 | 6% | 13 | 3% | ||
No. children with bilateral otoscopy | 401 | 90% | 424 | 94% | ||
No. children with at least one ear successfully assessed | 432 | 97% | 437 | 97% | ||
Clinical diagnosis
|
PCV7 432
|
PHiD-CV10 437
| ||||
normal | 32 | 7% | 41 | 9% | 2% [−1 to 6] | 0.29 |
OME | 175 | 41% | 222 | 51% | 10% [3-17] |
0.002
|
AOMwoP | 150 | 35% | 111 | 25% | −9% [−15 to −3] |
0.003
|
AOMwiP | 27 | 6% | 24 | 5% | −1% [−4 to 2] | 0.63 |
Dry Perforation | 8 | 2% | 5 | 1% | −0.7% [−2 to 1] | 0.39 |
CSOM | 40 | 9% | 34 | 8% | −1% [−5 to 2] | 0.43 |
Bilateral OME* | 136/401 | 34% | 191/424 | 45% | 11% [4-17] |
0.001
|
Unilateral OME* | 24/401 | 6% | 25/424 | 6% | 0.1% [−3 to 3] |
1.000
|
Combination OM categories
| ||||||
Any suppurative OM (AOMwoP, AOMwiP, CSOM) | 217 | 51% | 169 | 39% | −12% [−19 to −5] |
0.0004
|
Any TMP (AOMwiP, DP, CSOM) | 75 | 17% | 63 | 14% | −3% [−8 to 2] | 0.24 |
Any ear pain (today or last night) | 34/408 | 8% | 17/337 | 5% | −3% [−7 to 0.2] | 0.08 |
Non-mixed PCV schedules
|
PCV7-only 353**
|
PHiD-CV10-only 319
| ||||
No. children with at least one ear successfully assessed | 345 | 98% | 309 | 97% | ||
Normal | 24 | 7% | 31 | 10% | 3% [−1 to 7] | 0.16 |
OME | 127 | 37% | 152 | 49% | 12% [5 to 20] |
0.001
|
Any suppurative OM (AOMwoP, AOMwiP, CSOM) | 191 | 56% | 121 | 40% | −16% [−24 to −8] |
<0.0001
|
Any TMP (AOMwiP, DP, CSOM) | 62 | 18% | 48 | 16% | −2% [−8 to 3] | 0.40 |
Age and any suppurative OM
PCV7 424* | PHiD-CV10 432* | Absolute risk difference [95%CI] | P value | |||
---|---|---|---|---|---|---|
Age group | n | % | n | % | ||
3 to <6 | 4/8 | 50% | 3/9 | 33% | −17% [−63 to 30] | 0.48 |
6 to <9 | 34/47 | 71% | 33/60 | 55% | −16% [−34 to 2] | 0.09 |
9 to <12 | 27/38 | 71% | 21/45 | 47% | −24% [−45 to −4] |
0.03
|
12 to <18 | 50/84 | 59% | 46/114 | 40% | −19% [−33 to −5] |
0.008
|
18 to <24 | 54/98 | 55% | 39/101 | 39% | −16% [−30 to −3] |
0.02
|
24 to <36 | 48/148 | 32% | 27/103 | 26% | −6% [−18 to 5] | 0.29 |
Univariate and multivariate analyses of risk factors for any suppurative OM
With suppurative OM** | UNI-VARIATE OR | 95% CI | p | MULTI-VARIATE OR | 95% CI | P* | |
---|---|---|---|---|---|---|---|
Vaccine group | |||||||
PCV7 | 51% | ||||||
PHiD-CV10 | 39% | 0.64 | 0.48 to 0.86 |
0.003
| 0.58 | 0.41 to 0.80 |
0.001
|
Children under age of 5 years in household | |||||||
0 | 39% |
0.003
|
0.009
| ||||
1 | 47% | 1.43 | 0.98 to 2.10 | 1.34 | 0.91 to 1.98 | ||
2 | 53% | 1.85 | 1.12 to 3.07 | 1.66 | 0.99 to 2.80 | ||
3+ | 60% | 2.42 | 1.46 to 3.99 | 2.36 | 1.41 to 4.00 | ||
Age group (years) | |||||||
< 1 year | 58% |
0.000
|
0.000
| ||||
1 to < 2 years | 47% | 0.70 | 0.49 to 1.0 | 0.72 | 0.50 to 1.04 | ||
2 to < 3 years | 30% | 0.33 | 0.22 to 0.49 | 0.31 | 0.20 to 0.47 | ||
Gender | |||||||
Male | 41% | ||||||
Female | 49% | 1.41 | 1.07 to 1.86 |
0.016
| 1.46 | 1.07 to 1.92 |
0.016
|
Antibiotics prescribed in previous 5 weeks | |||||||
None | 44% | ||||||
Any | 47% | 1.21 | 0.90 to 1.62 | 0.20 | 1.24 | 0.91 to 1.69 | 0.17 |
Haemoglobin | |||||||
> = 11 mg/dL | 42% | ||||||
<11 mg/dL | 49% | 1.28 | 0.93 to 1.75 | 0.13 | |||
Child care attendance | |||||||
none | 47% | ||||||
any | 47% | 1.03 | 0.64 to 1.67 | 0.91 | |||
Sibling history of OM “runny ears’ | |||||||
No | 47% | ||||||
Yes | 47% | 0.98 | 0.69 to 1.39 | 0.90 | |||
Maternal smoking | |||||||
No | 46% | ||||||
Yes | 48% | 1.11 | 0.80 to 1.53 | 0.53 | |||
Child near campfire last week | |||||||
No | 48% | ||||||
Yes | 47% | 0.89 | 0.63 to 1.35 | 0.51 | |||
Maternal age at birth of this child | |||||||
> = 21 yrs | 43% | ||||||
< 21 yrs | 52% | 1.39 | 0.97 to 1.99 | 0.07 | |||
Maternal education | |||||||
no certificate | 46% | ||||||
certificate | 49% | 1.07 | 0.74 to 1.57 | 0.71 | |||
Breastfed | |||||||
Never | 51% | ||||||
Some | 47% | 0.86 | 0.45 to 1.65 | 0.65 | |||
Pacifier | |||||||
Never | 47% | ||||||
Some | 47% | 1.02 | 0.70 to 1.54 | 0.91 | |||
Gestational age | |||||||
> = 32 weeks | 45% | ||||||
< 32 weeks | 54% | 1.3 | 0.60 to 3.06 | 0.51 |